FDA says 561 deaths tied to recalled Philips sleep apnea machines

Watching the way they handled this recall so poorly got me to do whatever it took to reduce my snoring and mild sleep apnea down to almost nothing (mouth/throat/tongue exercises did the most followed by head positioning). The stories of people who relied on their CPAP caught up in it were heartbreaking and nerve wracking.

Edit: I used a combination of the Snore Gym app and Vik Veer's videos on Youtube. After a couple months my snoring became barely audible, but it doesn't always work for everyone. I was tilting my head down at night which blocked off my throat somewhat, so I lifted my head up higher with a bigger pillow.

I had a coworker that himself is getting a jaw surgery because his bone structure would sometimes make him stop breathing while sleeping for short moments.

His brother apparently was a horrible snorer, but that was due to his nose, that the "skin" would collapse inwards when he took a sharp breath through his nose, instead of expanding. Apparently just having some kind of tape on his nose to stop that from happening while sleeping made a huge difference.

Fellow mouth taper here! It’s a must for shared hotel rooms. I have no idea about the safety or effectiveness for sleep apnea, but it significantly (N=1) improves others’ sleep.

I am not a medical professional but was recently officially diagnosed with sleep apnea and am using a CPAP. I was taping my mouth, which did work. However, I was strongly advised against doing this when I mentioned this to my sleep specialist. It’s possible for your nose to get obstructed and you can risk suffocating.

> However, I was strongly advised against doing this when I mentioned this to my sleep specialist. It’s possible for your nose to get obstructed and you can risk suffocating

CPAP user here. I tape my mouth. The risk of suffocating due to a blocked nose seems low to me, for two reasons. First, because I can simply do a one-sided smile and breathe normally through my mouth -- I've tried many times for funsies and it's never failed. Second, because you should always fold the two bottom corners of the tape to facilitate its quick removal in the morning anyway.

The real risk of taping your mouth at night, in my opinion, is if there's any chance of vomiting. Without any other way to go, you would aspirate the vomit and that's bad. What I do to reduce that risk is not eating for three hours before using the CPAP.

So why go through all that effort when one could simply use a full face CPAP mask? That's because it is difficult to produce an airtight seal around your whole face, which is necessary for CPAP therapy to work. Creating a seal around your nose is much easier and the smaller size of a nasal nask allows you to sleep on your side, which for most people means you can get away with using lower pressures, which in turn are more comfortable.

Vomitting without waking up is next to impossible unless you are blackout drunk.

I can't even almost vomit without waking up. I was wondering how anyone could sleep through actually doing it!

It would seem the risk of death from the CPAP is far higher than that of mouth taping. A quick google and I can’t find any injuries or deaths from mouth taping but here we have confirmed hundreds of deaths from faulty CPAP machines

What tape works for you?

I like the 2” x 100’ 3M surgical tape although i don’t remember what exact variant. Medipore, micropore, maybe both.

holy shit I'm the brother except I'm an only child. need to try out the tape

You may also want to check out "Max-Air Nose Cones".

Hey, cool, Amazon link to "Max-Air Nose Cones" instead lists AIRMAX Nose Cones. Gotta love that site.

Hi, Mr. Calhoun! I’m sorry this is such an unorthodox way of reaching out to you, and I know this is probably off topic for the original thread, but I couldn’t really find another way to contact you. I’m trying to get in touch with you about your raspberry pi TV project. I’m a 16 year old high school student, and my best friend loves retro tv and custom gifts, so I figured a great going away to college gift would be a project like this, loaded with all his favorite old (legally obtained) tv shows, and the videos of various musicals we’ve done together. I’ve been looking for a project very similar to yours for a few months now, and the closest thing I’ve found is a video describing a portable version of the project by a YouTube channel called Irish Craig Party. Unfortunately, it was the only video on the channel, the comments were turned off, and they had zero social media/github attached to the channel. I had to keep looking around for similar projects. I was totally willing to do some of the coding myself, but some fundamental challenges like the scheduling or the real time playback were a bit too intense for my admittedly barebones coding skills. Now I humbly come to you. You had mentioned that you were planning to open source it in a thread from a while ago, but you were debugging. Is there any way to get the code for this? I already have the vast majority of the parts, I’m willing to debug and modify it in any way, I just need the foundations. Thank you for hearing me out, I’m sorry for not finding a better way to reach out, and thank you for your time.

There's also `nasal strips` - plastic strips with adhesive (like a plaster) to open up the upper-nose.

Jaw surgery helps open up the airways by moving the jaw forward.

Many people can get a mouthguard-type thing that has the same effect.

No they can't. It costs an obscene amount of money and insurance won't cover it unless you get a sleep study ($$$$$) and it proves you have sleep apnea. Don't have apnea but still snore? Tough luck!

My insurance paid for all of that without a quibble after my family doctor made a referral. My insurance company has many customers. So I am going to stick with "many people".

I hope you’ve done an actual sleep test to confirm your sleep apnea has improved.

Snoring is a useful but not 100% correlated marker for sleep apnea. It’s very possible to improve snoring without reducing the sleep apnea itself.

I'm 39 years old. Perfect shape, no health issues, don't smoke, don't drink, regular exercise.

About a year ago, Out of NOWHERE I began snoring at night, and only when laying on my back. Never snored my entire life. No other position. But it drives my wife crazy. The problem is we cosleep with our baby, and laying on my back is the safest position.

I don't have apnea so I don't qualify for insurance for any kind of mouthpiece. The ENT just laughs me off like it's no big deal. My nose is fine and he's zero help.

I know it's something to do with my tongue but I have no idea what to do about it.

I've tried thin pillows, thick ones, no pillows. Doesn't help.

I thought everyone snores sleeping on their back.

Uh... no? Not at all.

Nope. It’s common and can be an indicator for apnea etc..

Normally sleeping on your back maximizes airflow instead of creating an obstruction (snoring)

I had a similar issue.

Absolutely anecdotal but a jaw alignment mouth guard worked for me.

ZQuiet is that one I have: https://zquiet-usa.com/

I havnt used them but Zyppah looks like it is doing the same thing: https://zyppah.com/

The idea is to force your jaw into a slightly different position which keeps your tongue from falling back and blocking your airway.

I tried it before a sleep machine because its like $50. It works well enough and my wife doesnt complain about snoring anymore if I sleep on my back.

The problem with these generic non-fitted ones I heard is it can really hurt your teeth (possibly even negatively impact them over prolonged use).

The problem is we cosleep with our baby, and laying on my back is the safest position.

No, the safest position is not having an infant in your bed with you while sleeping.

insurance

I was better off buying the machine outside of insurance. Insurance was testing to force me through some sort of rent-to-buy thing where the machine would get taken away if not used a certain number of hours per week. My out of pocket cost for the rental added up to significantly more that just buying the machine outright, and by buying the machine myself I didn’t have to share that data with the insurance company.

Presumably they also can sense how they feel when they wake up. An unencumbered night feels completely different than a night hindered by sleep apnea, snoring or otherwise.

Not for me, no change before or after the CPAP machine, but I had an over 100 AHI during 2 separate sleep lab assessments.

Wait are you claiming your still wake up feeling like shit even though you are objectively getting better sleep? Or just that you haven't been able to improve your sleep apnea symptoms (AHI count) despite treatment so you still wake up feeling like shit?

Because even if there are some outliers like yourself, I can confidently claim that most people can correlate improvements in sleep apnea symptoms and sleep quality more generally with the way the feel in the morning.

I don’t feel a difference, and in some ways I feel worse, such as when there is a slight leak which leads to my tank running dry. If I don’t use the machine then sometimes in the middle of the afternoon I think about just laying down on the floor wherever I am. I never feel great after using the machine though, and I’ve looked at the log data and it is working. The only reason I keep using the machine is that my spouse gets better sleep.

My sleep apnea was already extremely mild to the point where a sleep doctor told me I could just sleep on my side and not experience it, but I appreciate the concern.

I did none of that. Instead, what worked for me was to change my lifestyle. Paced walk half an hour and lift for ten minutes everyday. Reduce smoking to rare occasions. Eat less, lose weight, and finally get those teeth done.

With the exception of losing weight (already a 22 BMI) I tried pretty all of this to no avail. Turns out I had a deviated septum and surgery fixed the problem. As a bonus, I can easily breathe through my nose now.

Septoplasty and tubinate reduction surgery was one of the best choices of my life. Lifelong allergy sufferer, being able to truly breathe was profound.

I have a deviated septum, but the doctors in the US doesn't think its medically necessary to do Septoplasty and I also have a sleep apnea, come to think I should get this done.

Not sure on the accuracy or if it applies to you, but prior to getting the septoplasty my ENT did mention it might not make a big difference if overweight or obese and so often doesn’t recommend it in those cases.

For comparison, I used some of those nasal strips before surgery and the post-surgery were very comparable, so that might be an inexpensive option to try? I also recall someone mentioning some sort of nose plug thing from Amazon you could get that does the same thing.

tubinate reduction surgery

I've read horror stories about that. Apparently a lot of the problems could be solved by teaching kids how to breathe (no mouth breathing), having a proper diet (chewing), &c. of course once you're fucked you're fucked and you have to go to these extremes to get your life back. It's like our lifestyle is slowly evolving us out of this planet

That's great! I didn't want to give the impression that I had the one and only solution to everyone, so what matters is whatever works for you.

There is the possibility TENS may be of use as well

https://www.news-medical.net/news/20230803/TENS-machine-may-...

I recently found a line of knowledge-practice relating to holistic dentistry specifically that acknowledges and addresses biomechanical-physiological aspects of the bite. E.g. occlusion issues with the teeth, where the jaw is unable to land and find a comfortable-relaxed position - and so jaw/head muscles continue to engage, spasm, or guard completely - causing a potential systematic cascading failure that has a "ridiculous" amount of severe symptoms possible, and why it's ridiculous - is that you'd think this would be part of mainstream dentistry practices because of how foundational the bite position is, yet it's not mainstream; the first diagnostic is using a device called BioPak, hooked up to the head/face at different position with electrodes, it monitors muscle activity - and can tell which specific muscles are firing-resting and at what rate.

They also use TENS as part of their protocol.

It took me 8 years to stumble upon finding the practice-protocol for a problem I figured I had but couldn't find dentists to solve for it.

Any links? What is it called?

Might be this: https://www.digitaldental.com.au/products/biopak/

Yes, that's one of the tools they use.

The training for dentists and full protocol-processes followed, and has been evolving, is from Las Vegas Institute - https://www.lviglobal.com

They have a directory listing of the dentists who have done their various courses. NOTE: Not all are up-to-date and so be sure to check they have the necessary relevant training, and that the course wasn't taken say 15 years ago; their dentists are recommended to regularly do courses to keep track of the improvements to their processes.

I've always wondered whether strong singer would snore... they got to have pretty decent control as well as well exercised muscles in that area

I recently saw this study, but it's almost 20 years old, I don't know if there's more recent data available.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360393/

"Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome: randomised controlled trial"

This deserves its own submission I think.

Results: significantly less snoring and sleep apnea. N=25

When my band toured and we could afford two hotel rooms, the singer would get one room and the rest of us would take the other. He was by far the loudest snorer of the 5 of us. Obviously just a funny anecdote but definitely not always the case that singers are the quiet sleepers. Or maybe he just needed more singing lessons.

As someone with apnea due to my anatomy (and AHI of 79 at that), I'm jealous. When I first got diagnosed more than 10 years ago the doctor thought I was obese seeing that. Nope, just bad luck. I'm fit, would hate to see how bad it would be otherwise.

Hey someone finally beat my high score of 58. I am obese, but I’ve been down as much as 50 pounds and up as much as 40 over my current, and it’s never really made a bit of difference. I have a very “tight” neck and throat and probably a deviated septum as well (on top of chronic nasal allergies/congestion), so yeah, I mouth breath a lot.

I’m due for a new machine soonish and I’m probably going to push for a bipap. I’m on an autos range of 17-20, and I will max that out sometimes. My scores are usually real good (like, sub 1.0), but the lack of headroom is concerning. 20 is as high as my machine (Resmed, luckily) goes, but my understanding is most bipaps go to 25, and the actual bilevel feature will likely be useful as well.

The resmed auto I have now is my favorite so far. Unfortunately did look up my old machine and it was one of the philips recalled ones, so that's not great to hear. I think I used it for roughly 6 years.

I did the deviated septum surgery which did help a lot but not for the reason most here say (since mine is anatomy related). It helped because I can now use a nose only mask which I find way more comfortable. I'd recommend it if you end up with headaches or pain due to the mask fit.

Just don't ever do the surgeries around the mouth (where they cut the Palate or stuff like that). Blows my mind they allow those given the terrible long term outcomes with scar tissue. It ends up making your apnea worse.

Invisalign actually helped my OSA a ton, that and nasal surgery for deviated septum brought my AHI from 40 down to 8.

Could you detail a bit what exercises you did and how you changed head position? Thanks!

I cured mine using tirzepatide once a week and fluticasone propionate nightly. Could never really get used to the CPAP.

Any good references for the exercises?

They should be required to replace all machines. They offered to give me $50 at one point because my machine is old.

I require a bipap with ASV machine due to having complex sleep apnea, and it costs at least a couple grand.

I ended up scrambling to get a replacement. The old one works perfectly fine, but I can’t safely use it due to the recall. Even after insurance I had to pay a grand out of pocket because they make you rent it at first.

If I'm waking up in the middle of the night choking / gasping for air (happens 1x or 2x a week at this point) is that a symptom of sleep apnea? I'll try to talk to a doc about it but I want to make sure I'm on the same page as some of you.

The article doesn't explain how these machines caused the deaths but the FDA announcement hints to it

A wide range of injuries has been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.

Yeah the reason for the recall is the foam inside disintegrating and being blown into the lungs.

I have two affected machines (one for each place I regularly sleep, I bought two so I didn't have to keep dragging them around). One of them is so bad that if I let it blow through a facemask for a day, the inside is all black. The air also smells really awful, like plastic fumes. Strange enough the other one which I use a lot more regularly fares a lot better.

Unfortunately Philips still didn't bother replacing mine. They are an awful company to deal with. I registered them over 2 years ago. Only last September I got an email back asking me to confirm some details. Since then again nothing. They don't even bother replying to requests for a timeline.

I still use the other machine regularly but it's also starting to taint masks when I test it with them. The local health service (I'm in Europe) lent me another brand but I really need these replaced.

The disregard for their customers' lives is really appalling. Not surprised people have actually died.

I paid big money for them too, 800 and 600 euro roughly (one of them is a full auto, the other isn't). A lot of money for what is basically a pressure fan in a box.

You're still using it?!

Not the OP, and I don't use a CPAP, but just living with sleep apnea is kind of horrible, and not harmless. It might be genuinely worth the small risks associated with the affected machines if the alternative is having to go back to untreated apnea.

I understand that some people can't afford to buy a machine on their own, but damn that would be $700 I'd totally spend. Buying a different brand in the US is super easy.

The problem is that I moved countries in the meantime and here it's not quite so easy buying one on your own :(

You should have a look at your local craigslist alternative (like OLX in europe) or facebook marketplace. Lots of people sell their CPAP machines.

Yes that's an option but I don't really like using a used one for hygiene reasons.

It's annoying that they're so restricted here with all the medical red tape. They can't even go high enough to do actual damage. It's not like a respirator.

You can probably order one from the US if you still have your old Rx somewhere.

Yeah of course. Especially while I didn't have an alternative yet. I have this machine for a reason and untreated sleep apnea is also dangerous long term. It's also very hard to live while sleeping so badly.

I'm not using the bad one though. The one that smells and blackens face masks. Only the other one. I regularly let it blow into a mask for a day to verify.

Have you considered the oral appliances? They don't work if your apnea is really severe but they're pretty awesome if it works for you.

I tried one before I had the machine but it gave me really painful teeth and didn't help enough.

I used to wake up with really painful teeth and I also felt them starting to misalign. Like they were pushing my teeth around like braces.

Yeah, oral appliances don't fix the actual problem: tongue slacking into the back of the throat. It's the same reason a chin strap will just make you choke.

Supposedly you can "train" your tongue to stay in position with tongue & jaw exercises, but I saw no effect.

Oral appliance worked for me. It was sufficient to get my jaw in the right position.

if I let it blow through a facemask for a day, the inside is all black

CPAP, you were the chosen one! It was said that you would bring balance to the respiratory system, not leave it in darkness!

This is literally killing hundreds of people.

Darth Vader is fictionally killing billions of people.

That's like really bad, long term is there a risk of lung tissue fibrosis? I would expect it. I have the resmed but honestly I think a dental appliance might be better.

I also have a resmed now on loan. Way better machine yes.

But I don't know how long I'll have the loaner for and I want safe machines (that I paid a lot of money for) so I don't constantly have to drag it from place to place. That's why I got two in the first place.

That's like really bad, long term is there a risk of lung tissue fibrosis?

No idea to be honest. I'm not a doctor, just a patient.

Go to their secured email and email the documents including a current prescription for the appropriate machine (bipap vs autosv vs cpap etc). They have a call back number in the secure email, give them a call if needed. I got mine replaced after a lot of frustration but it was worth it.

I don't have a current prescription because the loaner machine was given to me instead. I did have one when I ordered the original of course. Though I lived in a different country back then.

But I can probably get a new prescription. Where do you find this secure email? I don't know what you mean, I only have the email address they emailed me from. Maybe that secure email is a US thing?

One of them is so bad that if I let it blow through a facemask for a day, the inside is all black.

This problem seem easy to recreate in a workshop or lab. There is really no excuse for this.

It was recalled there too, right? and pulled immediately in Europe too after this became public?! Does that mean they don't have to fix it or replace it immediately? Even car manufacturers are quicker to deal with recalls, even for much less dangerous stuff...

It does explain it, in the second, third paragraphs:

The FDA said that since April 2021 it has received more than 116,000 medical device reports of foam breaking down ... amid reports they were blowing gas and pieces of foam into the airways of those using the devices.

The reporting in this leaves a lot of questions. I can understand pieces of foam, but that the machines were harming people by blowing _gas_? The air that we breathe is a mixture of gases. What other type of harmful gas could a CPAP machine blow?

Polyester polyurethane particles which may or may not be visible to the naked eye. These particles can break down further into volatile organic compounds which are vapors. All of these are toxic and carcinogenic.

Volatile organic compounds from the foam breaking down. Formaldehyde was mentioned in some of the reporting.

I was recently diagnosed with sleep apnea. I'm on the very lower end of "moderate" (about 16 interruptions per hour), which fortunately means that the oral appliances are effective.

I've been suspicious of myself having sleep apnea for quite awhile now, and I held off on getting an official diagnosis in no small part because those CPAP machines give me anxiety; I'm somewhat convinced that I would never really get used to them, and I would wake up feeling like a head crab was attacking me. I had also heard some horror stories (not dissimilar to the Phillips machines) that really held me off.

I'm very grateful that the oral appliances exists, now even more so.

Where are you getting an oral appliance?

There are options on amazon for under $80 if you just want to try it and see if it helps.

...where? Do I just type "cpap mouth appliance"? Because that only seems to show me 15€ chinese crap with 2 stars out of 5.

They’re usually called “snore guards” or something like that. You boil them in water for five minutes and bite on them to mould them to your teeth.

I have one, it works alright. It lives in my backpack for when I forget to pack my prescribed oral appliance.

How confident are you that those devices don't contain toxic chemicals or radioactive material?

My sleep specialist doctor prescribed it. They had to do a scan of my mouth and after 3 weeks I got the mouthpiece in the mail.

how do you like it? Any issues with jaw pain or change in your bite? Also did your insurance cover it? I heard they are similarly priced as CPAPs.

I was recently diagnosed with severe OSA and I'm using a Resmed machine. I actually adapted to it immediately and I find the mask I'm using (Fisher and Paykel) to be comfortable.

Incredible life changer. You are fortunate that an appliance works, but I absolutely don't regret getting tested for it and using one.

I'm in my mid 30's and not obese, and didn't consider OSA to be likely but got tested due to grogginess and my Dad's recent diagnosis.

Similar story here, same equipment. 41 now, got it a few months ago. Life changing. I've done alright for myself business wise but I wonder what I could've accomplished had I went to the doctor earlier. I thought multiple naps a day, falling asleep on the desk were normal.

Ditto. Waking up after the first night with and realizing I've lived in a fog for a year or so.

Same. For me it was a lesson to complain to my Dr about everything (and also to have a regular doctor).

Yeah, whatever works! I might still get a CPAP eventually, particularly if my teeth start shifting from the appliance, but at least right now the mouthpiece is convenient and works just about perfect.

I'll do a bit of research on the Fisher and Paykel masks.

I got over all those fears and got a Resmed machine and I can't understand how people can sleep with it. Even if you somehow found the perfect mask, the thing is so loud you can forget about falling asleep. Imagine a constant "WHEEEEEZ... WHOOOOOOOZZZ...." right next to your ears, throughout the entire night. What a letdown.

I used the Airsense 10 and now the 11. The 11 is slightly louder, IMO. Neither were loud enough to bother me.

The perfect mask for me is the nose cushion. N30i for me, if anyone is curious.

This is what I use. I'm used to it but don't like it.

The noise doesn't bother me much. By the time it ramps up I'm asleep.

You likely have a faulty machine or insane acoustics in your room. My resmed airsense 10 is almost silent. If you are hearing exhausting in your mask then you might be exhausting into your pillow.

I wouldn't tolerate them without the Dreamwear mask, which is the least annoying mask available. At this point, I much prefer sleep with the CPAP than without it.

I held off on getting an official diagnosis in no small part because those CPAP machines give me anxiety

Thanks for this comment. I'm finally talking to a sleep doctor next week after years of putting it off for the very same reason. I'm hopeful it will be as life-changing as comments here suggest, but I'm still nervous about the remedies.

Don't let the machines put you off. They can be very comfortable, and like all things, you get used to having a mask on at night after some adjustment time. There's also settings to adjust the ramp pressure so you can fall asleep before the air pressure changes too dramatically.

Is this evidence that micro plastics are a serious health concern? If breathing air after it has flowed over foam is bad, we are slowly exposing ourselves to the same chemicals in hundreds of other ways.

This is not evidence of that. This machine delivers air at a positive pressure to force it through patients airways. The manufacturer used polyurethane foam instead of silicon foam. Moisture can make this foam break down. The device is likely to accumulate moisture due to it's purpose.

There are multiple unique factors here and microplastics are not involved.

Sorry but what you've said doesn't invalidate or answer what they asked.

The positive pressure used to force air through patients airways may have included broken down particulates of polyurethane foam? Of which may have been a major contributing factor to those health problems listed?

I believe you are “technically” correct, but colloquially, “microplastic health effects” are believed to come from drinking water and food. Not industrial pollution, which is apparently what Philips’ machine is microdosing their users with.

Sounds like we just need to wait to accumulate a bit more of them?

The dose makes the poison.

Not really. For many things there is no "safe" level, eg. airborne PM2.5 pollution or lead.

What you say is a bit of a common sense rule of thumb usually used for stuff we digest and poop out.

So that may rule out microplastics, which was shown to cross into tissue (including lungs) which means it would accumulate. And definitely nanoplastic, as those enter even individual cells and screw up their mechanics.

I wouldn't be surprised if in a few years we would consider no safe level of micro/nanoplastic exposure. Maybe we would already if not for the interests of manufacturers and oil industry.

I guess maybe you were agreeing with me but I responded as if you weren't

Colloquially, but we’re not talking colloquially, we’re talking about the Phillips machine and the fact that people’s lungs were being forced air of which included plastics.

I wasn't providing an answer I was presenting a question like what the other commenter was, which is could those health effects have come from microplastics emitted from the foam.

I’ve just read the FDA response which says:

The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include:

Irritation to the skin, eyes, nose, and respiratory tract (airway), Inflammatory response, Headache, Asthma, Toxic or cancer-causing effects to organs, such as kidneys and liver.

So it looks like it is the case

The FDA’s response to the recall says otherwise

The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include:

Irritation to the skin, eyes, nose, and respiratory tract (airway), Inflammatory response, Headache, Asthma, Toxic or cancer-causing effects to organs, such as kidneys and liver.

The problem is just about any foreign particulates at a high enough concentration will cause adverse effects when inhaled [1].

If the machine had a large residue of metal dust from manufacturing, or a grinding in the motor which made it into the airstream, there are severe consequences [2].

A similar issue could if there was some sort of wood dust [3] that made it into the airstream (e.g if they had a wood trim for aesthetics, and it was shaved down by the motor and made it into the air stream). If instead just the dampening of the wood caused mold spores to grow that made it into the air stream [4], that could also cause major issues.

So yes, in this case it's foam, but most foreign particulates are going to be a problem.

[1]: https://www.ccohs.ca/oshanswers/chemicals/lungs_dust.html#se...

[2]: https://lunginstitute.com/can-breathing-metal-dust-hurt-you/

[3]: https://www.osha.gov/wood-dust

[4]: https://www.mayoclinic.org/diseases-conditions/aspergillosis...

I think there’s plenty of reason to be concerned about microplastics, but not necessarily. There are plenty of fine particulates that you could eat to no ill effect which are very harmful if inhaled.

Almost any particulate matter that you can breathe in is a concern but microplastics are mostly ingested.

Is this evidence that micro plastics are a serious health concern?

Don't we know that for a while already ? The endocrine disrupting effect alone is a major concern.

I feel like we're back at the "is lead in gas really _that_ bad?"

You just know the people that brought this up internally at Philips were told “it’s not that simple, we can’t just…”.

Why is every CEO that held the reins during this debacle at Philips not in jail right now for manslaughter?

Because after decades of inbreeding between the legislators, law enforcement, and corporations, the justice system is completely broken.

I have a strong aversion to comments like this, because they come across as extremely generic. Are you really very knowledgeable about the Dutch justice system, that being where Philips is headquartered? Philips are gonna lose at least $400m from this: what makes you so certain that the justice system is "completely broken", or that manslaughter charges are what they deserve? Have you compared the justice system with, let's say, Russian justice or Zimbabwean justice? I think the latter are a great deal more broken.

Casual cynicism is as foolish as casual naivety, and more toxic and dangerous.

They killed people for money. They will get away with it because the managerial class is generally not held responsible for their actions. One legal system is not immune from criticism just because worse ones exist.

true.

thou i would argue that dead people are a negative externality of most major industries (think tabaco, oil, cars)

I'd feel differently if some people died because their CPAP wasn't operating as well as it should have, too low pressure, etc. But this was a design decision to put material in the airflow that you should know would degrade and cause people to aspirate. It's pretty unusual negligence of design, followed by denial and a coverup.

I'd go as far as to say that mistakes will always happen, so even if this was a design defect, it could've been handled in a way that doesn't result in people going to prison.

As soon as you catch wind of this sort of issue, this is what should be legally required to happen in order to escape lengthy prison time:

- immediately take full responsibility and take your products off the market

- work with relevant agencies to identify impact and produce a list of everyone who could be affected

- recall every device that could possibly suffer from the same issue

- offer to pay for preventative medical exams for any customer who's suffering from any early symptoms

- offer at least 7-8 figure sum of money to each victim's family

- fix the design defect and publish a full transparency report that details the issue and how it was addressed, verified by a relevant agency

Just to rub it in, Philips gets to settle without admitting any wrongdoing.

They killed at least 561 people, knew about it, covered it up for years, and you want to debate whether manslaughter charges might be appropriate? Any justice system which allows that to happen without imprisoning the people responsible for the rest of their lives is completely broken, says me.

It's not casual cynicism either, at this point it's professional cynicism because we've all seen this film 1000 times before and we know how it typically ends. Personally I'd reserve the use of words such as "toxic" and "dangerous" for Philips' CPAP machines and their leadership.

They're going to pay less than $1 million per victim while their annual profits are in the billions. Would you feel good about that amount if they killed your dad, mom, brother, sister, son or daughter?

To add onto this, this article describes the absurdity of this situation and complete indifference to human life at Philips. Notably, they kept using the same problematic foam for over a decade after they knew it was dangerous.

https://www.propublica.org/article/philips-kept-warnings-abo...

In June 2010, Philips found that a machine sent back to the company by a customer was contaminated with “foam particles,” FDA records show. Rather than alerting the government as federal law required, records reveal that the company kept the report about the problem in-house for the next decade.

A similar report came in the following year, describing another CPAP with “black contamination.” That, too, was not turned over to federal regulators.

Another report was also held back, this one from a patient who found particles in the tube that carries air to the nose and mouth. A complaint two years later described a 3-year-old girl who was using a ventilator with a filter that had turned black.

By the end of 2014 — about six years after Philips started using the foam — more than 500 reports from health care workers, patients and others had flooded the company in a pattern that would not be revealed to the government or the public for years, the records show.

[...]

In 2015, Philips was moving to dominate the market, but the foam problem threatened the momentum. That year, a company engineer questioned the supplier, emailing, “Have you ever seen this occur to the foam?” company records show.

Two and a half years later, as new complaints came in from Australia, Philips scientists were summoned to a series of emergency meetings outside Pittsburgh to come up with a plan. The day after one of the sessions, another engineer detailed the safety risk in an email to the foam supplier.

“The material sheds and is pulled into the ventilator air path. As you can imagine, this is not a good situation for our users,” engineer Vincent Testa wrote that April, sharing photos of the foam breaking apart. “I flagged this message with high importance since we are addressing a potential safety concern.”

Without alerting the FDA or the public, the company started replacing the foam in some ventilators but once again left the vast majority of machines untouched, including the widely used DreamStation, FDA records show. Testa did not respond to interview requests.

Customers weren’t told even as debris turned up on their bedsheets, pillows and faces.

[...]

In the spring of 2020, as the COVID-19 virus raged and thousands died, Philips boosted production of another ventilator to help ease the burden on overwhelmed intensive care units.

These, too, were built with the same foam.

Over the course of the year, operating profits from ventilators, CPAP machines and other devices soared to about $800 million, more than double what they were the year before, according to reports by Philips’ parent company.

Response from customers “remains very positive, resulting in market share gains,” Royal Philips’ then-CEO Frans van Houten said during a fourth-quarter earnings call.

During the call, van Houten made no mention of the turmoil inside the company, including internal studies that showed the DreamStation had failed emissions testing for volatile organic compounds. The chemicals can be found in everyday products, such as gasoline, paints and pesticides, but in breathing machines, the fumes can be inhaled for hours at a stretch.

[...]

In April 2021, Philips unveiled the DreamStation 2, a sleeker and more advanced model with a color touch screen and more personalized settings. Another change separated the new model from the old one: Philips chose different foam, one that would hold up in heat and humidity.

With the launch of the new device, the company’s stock price reached a high of $61 a share — more than double what it was five years earlier.

It was only then, during a late-April earnings call with investors, that Philips for the first time revealed that the foam it had used for years in millions of machines was at risk of breaking down.

“Regretfully, we have identified possible risks,” said then-CEO van Houten, adding that the company had set aside 250 million euros to deal with the problem. “We are taking proactive action here.”

Van Houten went on to reassure investors: “The device is safe to be continued to use to the best of our knowledge at this time.”

[...]

As news of the problem spread, customers and others stepped forward by the thousands, describing emergency room visits and sudden illnesses in reports submitted to Philips and the government. The reports detailed nearly 2,000 cases of cancer, 600 liver and kidney illnesses and 17,000 respiratory ailments.

Philips said the reports of illnesses and injuries are not evidence that its devices caused harm. But six medical experts who spoke to ProPublica and the Post-Gazette said the complaints are an indisputable indicator of a sprawling public health crisis. They said more harm is likely to emerge in coming years, much as the effects of tobacco and asbestos only became clear decades later.

Emphasis mine.

This is Hacker News, casual cynicism is the name of the game here

Because when a corporation has put profit over people and the people were harmed or killed, that corporation deserves to be completely dismantled and the owners (yes: shareholders too) deserve jail.

Until capitalism stops treating people like they are a renewable resource to squeeze profit from - capitalists need to be put on notice that acting like criminals means they get treated like criminals.

Stop. Pretending. There. Are. Good. Corporations.

Don't forget that if corporations are people, then this might be grounds for the corporate death penalty.

The way that would work is the Philips name would be retired and all patents, copyrights and trademarks would be released to the public domain. All ownership would end the same way as when someone dies, and assets would be distributed to next of kin. The company might be broken up and sold at auction, with the proceeds donated to shareholders and any other owners/investors. Or parts of it could be sold to other companies to pay for lawsuits and other costs, like when splitting up a company under antitrust laws.

Looks like Philips has a market cap of just over $20 billion. Shifting that intellectual property to the public could start an open source revolution in medical research. The ripple effects of that are hard to predict, but might put more of a focus on cures than treatments.

We could see gene therapy for the primary inherited conditions arriving years earlier than expected. Conditions that at least 10% of the population have to deal with every single day that affect quality of life and aren't being addressed by for-profit corporations. Imagine the relief for mental health that would come through these cures, reducing the isolation and alienation for the people who have been forced to internalize their situations because the larger population is oblivious to their experiences.

Gene therapies start around $1 million per person. But the main cost lies in research, not application. Why are we performing medical research under a for-profit model? We didn't use to.

Recent trends show that large corporations are focusing on profits over the health of their customers. If they've abandoned their charters, then maybe it's time for alternative approaches. IMHO the priority today should be large epidemiological studies to provide big data for AI to spot the correlations which lead to cures. But the astronomical profits of big pharma have diverted those funds to the point that those companies are slowing progress and increasing costs for all of us.

Good question. They basically sat on reports instead of notifying authorities. Criminal negligence.

A HN trope is that software engineers are slipshod and real engineers are licensed craftsmen. Let me tell you this, I haven't killed anyone and if software I'm about to write would, I just wouldn't.

The standards of these industries have a long way to go before they catch up to us.

HN is filled with people who think they could do better than Boeing, FAA ATC and medical EHRs.

Every one of them is wrong.

You do realize some of us here actually have worked in those industries.

I don’t agree. It’s not about being a better engineer than those at Boeing etc. (you might be right about that but it’s totally tangential).

It’s about being open and transparent about potential risks, being transparent about your mistakes and not outright illegally concealing them and cheating.

The Boeing problem is management and easy to do better than. Penny-pinch less on safety and inspections and leave everything else alone.

I've never seen someone say they could do better than air traffic controllers themselves. If this is about paying more and hiring more people... that's also something the average person is capable of handling.

Strange take. Just because your work doesn't have the possibility of hurting someone doesn't make you any better or higher standard...

That's what engineering is about: creating value efficiently without causing inadvertent damage. When I have to risk lives in order to create value, I simply choose not to. Instead, I just create value without risking lives. Engineering. Quality. Cost/Benefit. Benefit/Risk. Not just slapping together metal and plastic while wearing an iron ring. None of these titles granted by men. Just physics, electricity, and my mind.

It is precisely because I am less likely to kill people that I am a better engineer. Picking your battles is part of fighting.

It does make it less likely they’ll have blood on their hands. Some would consider that better.

You're not an engineer.

And yet I'm better at the job than those who call themselves that. They give each other titles. I create value.

Tech has less of a competency crisis than other industries. Even though they have better ISO standards supposedly.

Pro Publica has done a lot of good reporting on this topic.

https://www.propublica.org/article/philips-kept-warnings-abo...

Blood boiling.

A complete failure of the QMS.

I know the FDA wants/needs to keep Philips around to manage the recall, and like... people with CPAPs need them, but I really wish they would just terminate all of Philips' licenses/approvals/clearances right now. I hope the DOJ has bigger penalties to lay down.

FDA's post market surveillance relies on manufacturers to be sufficiently honest. Philips sat on thousands of reports for over a decade. This is simply unacceptable. For the FDA to be able to say with a straight face that their post market surveillance has value, they need stronger assurances that manufactures will play by the rules, and I feel that means really making an example of Philips here.

I've worked in medical devices before, and I am quite aware of how easily QMS and SOP can diffuse responsibility. It's so easy as a line worker/line manager/middle manager to shrug and go "well, I did my role as prescribed by QMS and SOP - it's not my problem that we're sitting on 10k medical device reports that we should be notifying the FDA about". And that's a huge problem.

Obviously upper management has the most blame here, but no one involved is blameless. The QMS has some boilerplate about how everyone is responsible for quality. If that's true, then everyone involved is also responsible in some part.

I know terminating all of Philips' licenses for like 5 years or something will basically make a lot of people jobless. But like 500 people died because some assholes decided to go for the $$$, and everyone else involved let it happen. That's not an acceptable corporate standard.

But like 500 people died because some assholes decided to go for the $$$

500 people died so far and that we know of.

So yeah, fully agree with your points.

The title says 561 right now.

The FDA is preventing Philips from selling any sleep apnea devices in the US for a few years until some unspecified manufacturing quality control problem is fixed. This is interesting because the new devices don’t use the same foam and don’t have this defect. I’m unsure if this ban affects ventilators which were also affected by the foam defect. Still, according to the ProPublica reporting Philips already made bank the last few years. They’re also trying to limit damages by putting all blame on the US subsidiary.

Unspecified? What the fuck. There is no reason Phillips should enjoy any sort confidentiality here. Not before, and especially not now.

TechAltar on youtube posted a video last year about the decline of Philips. They apparently just excel at toothbrushes, smart bulbs, and shavers nowadays, and cash in on the name through licensing. [1] It is an unfortunate tragedy that so many people died because a corporation did the wrong things.

The US FDA has many flaws to be sure, and they are not known for making fast decisions. It sounds like more lives could have been saved.

A member of my family fortunately stopped using their device when it was recalled and has struggled to find a replacement.

[1] https://youtu.be/WE58YisgFeQ?si=3mWRxg-b9WOPFKQm

They apparently just excel at toothbrushes, smart bulbs, and shavers nowadays

Maybe in the consumer space. But they’re still a huge conglomerate, and one of the biggest MedTech companies in the world. I’m not questioning their malfeasance here, but I doubt it’s going to impact sales on their MRI, CT, EKG… devices very much.

Fair point, the apparent shift in their consumer electronics division (a decline in innovation) may be partially or entirely unrelated to the factors leading to this incident.

However the brand as a whole is not enjoying its day in the sun, and I hope more people do not get hurt or worse.

The same exact thing happened to Olympus. For some reason medtech is where corporations go to sleep, and make tons and tons of money haha.

For some reason

Yeah, heavy regulation is that reason. Somehow, heavy regulation that doesn't kick-in when they do something wrong, but only kicks-in when a smaller company wants to make a first product.

But well, it's an area that needs regulation. It's just the format that isn't looking good.

What was most shocking to me was not the corporate incompetence (I'm used to that), but the fact that 5 million devices had been recalled. I had no idea there were so many people that used a sleep apnea machine.

I'm wondering if common wisdom will change dramatically in the next 50-100 years on human lifestyles, and most of these diseases will be largely resolved (like gout was for the upper classes of a few centuries ago).

I'm in shape, "healthy" but I have a thick neck that causes my issue. It's not just eating junk food and being fat.

Caught that you mentioned gout.

I recently got gout when I really pushed my body hard by running 4x my normal distance in one week, still worked out, kept eating lots of junk (lots of sugary stuff), and drinking 3-4 drinks a night regularly. I also got a cold. Right after that, I got hit with massive toe pain on one foot.

Thankfully it was just a little bit of prednisone but it caused me to back off drinking and eat less sweet things. I'm relatively fit (~35" waist, 203-205ish pounds at 6'1"), but I also dropped down about 5 pounds (was about 208-210) after that and will probably continue to lose more.

Sleep apnea is extremely common. And it appears to be correlated with having had corrective orthodontics, so may in fact be more common than previously.

I suffer from gout, and I'm not a few centuries old (yet).

The FDA said that since April 2021 it has received more than 116,000 medical device reports of foam breaking down in Philips CPAP (continuous positive airway pressure) machines and BiPAP sleep therapy devices

If I'm doing the math correctly...they are settling for $400 million...that's only~$3500 per complaint...that's not much money by any means...for a product that can cause cancer.

Please correct me if I am wrong.

for a product that can cause cancer.

Wonder if they'll ever go after alcohol and processed meat as known group 1 carcinogens (i.e. not the flimsy 'in the state of california' kind)

Affected (former) user. This settlement only applies to financial damages, I believe. If you read the link, or the class action documentation they sent to me, it does not apply to future costs related to medical monitoring or care.

From the class action settlement website (https://www.respironicscpap-elsettlement.com/) it looks like the $400 million is the estimated minimum, and this settlement is strictly about replacement of machines.

As both the article and settlement website say:

The settlement does not impact or release any claims for personal injuries or medical monitoring relief, according to the administrator with the U.S. District Court for the Western District of Pennsylvania.

In otherwords, there can be additional penalties/lawsuits more directly related to health damages.

Look at it on the bright side, they paid about 1000X per person compared to Equifax! (I jest).

It seems far worse (per capita) to get in a single fender bender than it does to cover up defective airbags for decades…

“Numbers sanctify my good friend” - Monsieur Verdoux

As someone from the Netherlands, the mismanagement at Philips has been almost physically painful to witness.

Philips used to be one of the big ones, like GE or Samsung. The mismanagement and slow deathmarch of a giant.

They used to own ASML, they used to own NXP, they owned Panasonic Batteries production I think, they had 30% of all shares in TSMC.

I mean you can forgive a single misstep, but if every single company you sell manages to becomes a de facto global leader in its industry the lack of foresight is something for the history books.

In hindsight, when the business men took over and moved the HQ to Amsterdam, where all the business people are, rather than in Eindhoven, where it was founded and where all the R&D and tech is, was the beginning of the end.

I remember Philips from when it was a synonym of quality and advanced technology. After being burned many times in the past 10 years, I just said enough is enough and won't ever buy anything with the Philips brand again.

Philips doesn't actually make any of that stuff. All of its consumer facing brands have been spun out or sold off. When you buy Philips headphones you're buying headphones by whatever Chinese company has the license this year.

It was just the same with Siemens, at a time one of Germany's most formidable industry giants... all split and sliced up by the MBA sharks. Truly sad to see.

On the other hand, it can be said that it can still go worse than that... just look at Boeing and how far they have fallen.

In hindsight, when the business men took over and moved the HQ to Amsterdam, where all the business people are, rather than in Eindhoven, where it was founded and where all the R&D and tech is, was the beginning of the end.

Hey! That sounds exactly like what happened to a US plane manufacturer that has regularly been in the news the last few years. But Philips has a slight lead in the death count for now.

I'm an obese man and had severe sleep apnea. Last year I got a sleep study and started using a BiPAP machine from ResMed. The different was night and day (sorry). Huge improvements to my energy levels and ability to just function during the day.

One thing that was really interesting in this process was understanding the machine itself. Being used to crappy consumer electronics, I was amazed at how robust the build quality was and the engineering involved. Every little eventuality of medical accessibility problems, or things that could go wrong were accounted for in the design somewhere. It's incredibly simple to use, easy to clean, easy to get spare parts if needed. I guess that's the quality you get when your device costs upwards of $2,000.

I just got back to trying to use my resmed and I am curious. How did you get used to wearing it? I am really trying but I am not having much luck.

Try out various masks. I bought one of each mask available and tried them all, ended up with the N20.

CPAP.com is great for decent prices and direct to consumer sales.

If the internal pressure is annoying, airtight earplugs help with keeping the sinus pressure even.

I just bought a ResMed CPAP myself. It does appear to be well constructed and the software seems to be much better too. Seems to be packed with internet connectivity "features" though so I'm gonna have to find a way to disable them. I'm also gonna try to reverse engineer the app in order to replace it with free software.

I use a RedMed. I wish I didn't have to. Anyone successfully 'lower their sleep apnea?' what protocol?

I had UPPP surgery. It wasn't pleasant, but after a follow on sleep study I no longer need a machine.

please don’t take this with offense, answering this question inherently involves assuming things about you. But as far as the literature i have read goes, at least 70% of OSA cases stem from obesity. [1]

As you probably know, the severity of OSA is quantified in something called the apnea-hypopnea index. For every SINGLE point of BMI reduction (5-8lbs depending on height), you achieve an AHI reduction of 6.7%. That’s absolutely massive. [2]

It’s still multifactorial, one’s anatomy can be varyingly predisposed for OSA, sometimes to the point of causing problems without obesity. But in general, that’s one hell of a bet.

!! I’m a medical student. I have not yet achieved the status of approbated physician. Please adjust your trust accordingly. I don’t think i have to spell out the difference between informed medical advice and comments on HN, my comment is already patronizing enough as is, but regardless.

[1]Resta, O., et al. "Sleep-related breathing disorders, loud snoring and excessive daytime sleepiness in obese subjects." International journal of obesity 25.5 (2001): 669-675.

[2] Fattal D, Hester S, Wendt L. Body weight and obstructive sleep apnea: a mathematical relationship between body mass index and apnea-hypopnea index in veterans. J Clin Sleep Med. 2022 Dec 1;18(12):2723-2729. doi: 10.5664/jcsm.10190. PMID: 35929587; PMCID: PMC9713905.

Around 2022 I was considering getting a new gen of Philips Dreamstation as a replacement for a beaten Resmed. Eventually I settled with a newer model of what I was using (AirSense 11).

Philips had a very good reputation in the community, their accessories are more affordable, more “boring” is a good way. I really preferred a company that way, but after all it sounds like I’ve dodged a bullet.

You can use Philips masks with ResMed machines. I've used Philips Respironics Nuance Pro masks with my AirSense 10 since day one.

I've never seen anything but Philips accessories for my Airsense (10 and now 11).

It seems only US residents are elligible for this recall and compensation. Seems like I'll have to pursue my own legal action.

Yeah this is what I don't get. Why wasn't it recalled by other health agencies before or after? Is the defect specific to the north american market?

I just contacted my lawyers. Turns out brazilian authorities suspended the import and sale of many Philips CPAP machines about 8 months ago. They'll help me get my money back. I'll be consulting a doctor too in order to see if there's any evidence that I've been harmed. I hope for their sake that my airways and lungs are fine.

Why wasn't it recalled by other health agencies before or after?

I don't know about other countries but the situation here in Brazil is similar.

Is the defect specific to the north american market?

Unlikely.

Could something like this cause IPF?

My father passed away a few years ago, after being diagnosed with IPF only about 1-1.5 years before passing. He had no past of being exposed to anything hazardous. His pulmonologist couldn’t ever figure out what could’ve caused it.

He was diagnosed with sleep apnea probably 15 or so years before passing, and used a CPAP nightly.

He eventually developed a nasty cough that never went away, and was finally diagnosed with IPF.

I’m not looking for any sort of retribution, more just possible answers or even just clues, since it’s not clear whether it was related to anything hereditary (I have 3 siblings).

And to be clear, I’m not even sure what brand/model he used (though my mom would likely know). So there’s a decent chance it’s unrelated.

I cross-posted this in a related thread [1], and @bagels dropped [2] this article that suggests it may be related:

https://www.aboutlawsuits.com/pulmonary-fibrosis-cpap-foam-l...

[1] https://news.ycombinator.com/item?id=39225674

[2] https://news.ycombinator.com/item?id=39226537

Jesus, wondering if I need to get checked out. I used one of these models for over 5 years :(

I hope the victims are going to hire John Barylick for their lawsuits against Philips.

Barylick knows his way around cheap PU foam that emits toxic particles in lethal doses. He helped the victims of the 2003 Station Nightclub fire, where 100 people died, mainly due to a toxic combination of PU and PE foam that was used for soundproofing. [1]

Watch his talk [2] if you feel you can stomach the horrendous details. It includes an excerpt from a bootleg digital sound recording made during the disaster. (The digital tape was later found amidst the ashes, next to the body of one of the victims, and fully restored.)

[1]: https://www.bu.edu/articles/2013/damages-station-nightclub/

[2]: https://youtu.be/zUndJG44Moc

I do honestly wonder what the next step is for folks like me who are affected by this. Does Philips pay my future medical bills if I get sick? Or do I just get a "we're sorry"?

Lawyer up. Anything else would be an unfair match. They have a legal team after all.

I was directly affected by this.

The recall was handled by a third party company, with a third party domain. All communications came from the third party domain.

I was unable to communicate with anyone from the manufacturers domain.

So I had to respond to emails from shadysounding.com and give my info to phone numbers on www.shadysounding.com.

I’m glad the recall list wasn’t leaked. Otherwise there would be tons of ID theft.

It can still be leaked.

my mandibular advancement device has been a very effective replacement for my CPAP!

I use an oral sleep appliance fitted by a dentist that specializes in treating sleep problems. Works well, but does take some getting used to.

I got diagnosed with sleep apnea due to “Laryngeal Apparatus- Collapse of epiglottis.”

Impression: DSL, IHT. Circumferential pharyngeal wall collapse in the Nasopharynx and Oropharynx. Epiglottis falling backwards.

The doctor told me there is no surgery or anything else but only CPAP as the solution :( I dread of a day when there is no electricity or the machine stopping working. Posting it here to see if anyone else knows a good doctor or have a similar issue!

1. A UPS?

My stepdad died, this past weekend, and his cause on the death cert was apnea. He used his machine religiously.

I need to stop by mom’s house and see which he used. It’s different than mine which is not the recalled type.

Very sorry for your loss.

I have a CPAP that has run for 5-8 hours a night every night for 9 years without any servicing. It’s amazing how robust medical devices can be.

My new one has LTE so that people know when I’m asleep to rob me, and a ton of other annoying “modern” features so I’m hoping this old one just keeps on going.

Resmed? You can disconnect the LTE antenna.

As the user of a Phillips Resprionics AirSense 10, I have a few thoughts.

1. The breakdown of foam is inevitable over time, maybe it should have been easily replaceable.

2. You can have my CPAP when you pry it from my cold dead fingers. I love my CPAP. It keeps me alive, and I'll swallow some foam to keep it.

3. Why isn't there an inline filter someone made to attach to the standard slimline (or heated) tubing that catches the foam chunks? Standard care instructions would be to check and empty it daily. If there is foam in it, immediately replace the foam piece (which I already said should have been user replaceable.) Maybe the foam WAS the filter, and such filters will always break down over time, especially in a device that gets tens of thousands of hours of use blowing humidified and heated air through it.

4. If a more expensive piece if foam would have fixed this, the idiot who did not demand such better foam should be called out publicly.

5. CPAPs save lives, and I think some mortality is expected/allowed if it gives better performance in trade.

6. There may soon be a shortage of these machines.

Enjoy your walks.

Like Boeing, a monopoly and lobbying power leads to "self-regulation" that gets people killed. The FDA, Congress, and Philips share blame.

Except Philips isn't really a monopoly here.

I worked at an agency in 2007-2008 that did some software work for Phillips related to CPAP machines. I remember they were not great clients to work with, they didn't continue after the short project.

The ex AG of Louisiana led a big crusade against these machines and personally suffered from them. May he rest in peace.

From a quick search of the FDA's adverse event database I only found five reports of events relating to the Philips Dreamstation from before 2020; only the fourth could related to the foam-dust:

One relating to filter problems: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/d...

One relating to skin irritation: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/d...

One with WiFi connectivity issues preventing configuration(!): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/d...

One waking up with a burning sensation in their nose and throat: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/d...

One shut down during the night leading to too-low oxygen levels leading to hospitalization and death: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/d...

It boggles the mind that Philips would chose to report the WiFi complaint, but not the foam-dust complaints. To me it makes it seem even more likely that this issue was deliberately suppressed by management.

How do they determine when one of these machines caused a death?

So how do we feel about this? 561 people dead? That's a lot! Way more than Boeing killed with the 737MAX. But OTOH, it's a Dutch company, so maybe we give them the benefit of the doubt?

I used one of these machines for a few years but stopped around 3 years ago. Should I be worried about long-term damage, and if so, how do I go about that?

I never noticed anything strange while using it, fwiw.

561 more lawsuits incoming

The only way these things get stopped is by having C-level go to jail.

I was reading the original source yesterday and it said 385. It must have been increased today. Experts have said that it could take years to know the full impact. Will the FDA keep us updated?

https://web.archive.org/web/20240131023937/https://www.fda.g...

Right now the FDA is trying to bring lab developed tests (LDTs) under FDA regulation, and their list of reasons is a bunch of anecdata, nothing like 500 deaths.

FDA does not provide evidence that they will provide better controls or improved safety, just that there were very minor reports from LDTs. CPAP machines were reclassified to class II devices in 2018, which requires that companies perform QMS and tell the FDA, and sometimes get audited.

LDTs require Lab Directors to take responsibility for the quality of a test at the risk of their license. Auditing is performed by professional societies, to high level. Public health labs and hospitals are furious about the extra, unnecessary paperwork that FDA taking this action would cause, for no apparent benefit.

The FDA allowing more than 500 deaths to happen is a massive indictment of their quality of auditing, and should signal that if they take over LDT regulation, more lives will be at risk.

Like this is just a tier below 9/11 level of disaster... I'm sure we'll see an appropriate response.

... stop selling the machines in the U.S.

WTF? So they're knowingly going to keep selling them elsewhere!?

Therac-25 meets the Station Nightclub fire.

Will people ever learn?

I'm confused - if I had one of these and they replaced it, is it safe or not?

Damn it! and you would thought going to well-known brand instead of Chinese crap would be more safe when it comes to somewhat medical machines. They need to be pushed to bankruptcy.

Sleep apnea is mostly a grift. Doctors go along with it because they don’t really care for obese people. It’s pretty scandalous if you look into it. The sleep apnea industry exists to sell machines first and foremost. Very little science involved.