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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Printable Version

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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Gideon - 07-25-2021

===July 21, 2021 - FDA has identified this as a Class I recall===

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

There are 2 entries on the FDA site, one for Risk of Exposure to Debris and Chemicals and the other Due to Potential Health Risks from PE-PUR Sound Abatement Foam

https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-continuous-and-non-continuous-ventilators-including-cpap-and

https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-ventilators-and-bipap-machines-due-potential-health-risks-pe-pur



Admin edit note:  Links fixed

FDA NOTICE [JULY 22 2021] - WakeUpTime - 07-25-2021

Re: <above>

Quote:
"Since the recall was announced, the FDA has recorded
more than 1,200 complaints and over 100 injuries
related to the issue."

[Philips CEO Frans van Houten] "In consultation with the relevant regulatory agencies and in close collaboration
with our customers and partners, we are working hard towards a resolution,
which includes the deployment of the updated instructions for use
and a comprehensive repair and replacement program for the affected devices."

[July 23 2021] https://www.aarp.org/health/conditions-treatments/info-2021/cpap-recalls.html
[July 22 2021] https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-continuous-and-non-continuous-ventilators-including-cpap-and

RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - hegel - 07-25-2021

Well, actually...since there are millions of users and 1200 complaints...and since I used to work in retail and know that many people issue specious complaints...and since 100 injuries "related" to the issue (out of millions of users) is ambiguous and anyway translates into a miniscule risk percentile for the population of users as a whole...this may not really be all that bad. Statistically speaking.

SO FAR. This is all still at the level of anecdote.

And no, I'm not covering for Philips. I'm presenting counter argument to the 'end of the world' scenarios sometimes floated about. AND, I wouldn't be surprised if things turned out worse, not better, than we've been hearing. But so far, foamgate looks to not be a death knell to PR users.

In other words, PR users may want to reconsider jumping off a cliff tomorrow.

RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Redrum - 07-25-2021

Yes Cases will go up, no one was expecting their cpap to make them sick

REGISTERED FDA COMPLAINTS & INJURIES - WakeUpTime - 07-26-2021

(07-25-2021, 07:54 PM)hegel Wrote: ...since there are millions of users and 1200 complaints...and since I used to work in retail and know that many people issue specious complaints...a miniscule risk percentile for the population of users as a whole...this may not really be all that bad. 
Philips may have a lot more to be concerned about than those early FDA complaints and injuries.  Unlike a traditional recall in the retail industry, the effects of Philips' faulty foam may manifest itself in a variety of ways; compared to an automotive recall that merely requires the replacement of the part, with the assumption that very few have been "injured" already and the faulty component was the obvious cause to a party's injuries or damages.

Most people likely have not made any prior connection between their Recalled Philips xPAP use and the onset of new ailments that subsequently arrived.  Prior to April and June 2021, no one would have thought that their Philips xPAP device might actually be the cause of newly developed ailments.  If I had any of the symptoms or illnesses below, after one year of a Recalled Philips xPAP device use, I might now consider registering a "complaint" or "injury", through the FDA or any other way.  We don't have to dispute it here, but it will be discussed more in-depth in legal environments.

Here's the possible links made by just one of several class-action lawsuits:

Quote:EXPOSURE TO DEGRADATION OF PHILIPS BREATHING MACHINES

The potential degradation of PE-PUR foam may lead to inhalation of degradation products and toxic chemicals.  This may increase the chance of lung injury and may also increase the risk of cancer.

Symptoms of exposure may include:
  • Headache
  • Throat irritation
  • Coughing
  • Lung inflammation
  • Nausea and vomiting
  • Carcinogenic effects

People who have suffered:
  • Airway irritation or inflammation
  • Breathing difficulty
  • Lung Damage
  • New or worsening asthma
  • Pneumonia
  • Lung cancer
  • Kidney cancer
  • Liver cancer
  • Colon cancer
  • Heart attack/heart failure
  • Stroke
  • Respiratory failure
  • Liver disease
  • Kidney disease


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 07-26-2021

(07-25-2021, 04:58 PM)WakeUpTime Wrote:  It's only my speculation, but I would guess that Philips was somehow dragged into announcing the recall after delaying as much as possible.  

Thank you...

This is speculation, except when I quote directly from Philips.

The first thing we all have to admit is how well Philips has been able to control the narrative of this story. 

 “In consultation with the relevant regulatory agencies,  Philips has decided to voluntarily issue a recall notification* to inform patients and customers of potential impacts on patient health and clinical use related to this issue, as well as for instructions on actions to be taken." 

This was carefully timed to come out after the release of their first-quarter earnings report, and the release of their new product line.

"The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family". 

'' To date, Philips has received a limited number of reports of possible patient impact due to foam degradation, and no reports to 
date regarding any patient death"

Let's break this down:
  • Philips was already consulting with the FDA prior to any announcements
  • The recalled products fall within the 5-year service life. They were expecting customers to trade up to the new product line.
  • Philips says they have received only limited reports of patient medical issues. I do not think so. I think the number was getting larger and larger. To keep that story from getting to the outside world, and out of their control the strategy was changed and they went to the FDA and were allowed to issue their involuntary recall.
  • Philips would have no way in the world to know-how or the cause of death. how many times have you heard this being used to explain some of the deaths due to covid, " Complications from pre-existing conditions"
  • Doctors had no knowledge of the potential side effects of these recalled products. They had no way to know if new covid patients already had compromised or degraded immune systems 
Messaging:
   
No matter what you read or from who, even the FDA, everyone is completely quoting from the Philips Recall Notice. They have managed to totally insulate themselves, and stay ahead of any negative news. 

The sad truth is that we are dealing with a super large multinational company. unlimited resources and the manufacturer of large complex systems that the medical industry relies on. 

Unless someone from within the company comes forward, this will be a very hard nut to crack open........SO SAD   
 

RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 07-26-2021

"Since the recall was announced, the FDA has recorded more than 1,200 complaints and over 100 injuries related to the issue."

The keywords here are, "Since the recall". June 14, 2021. These products hit the market in July of 2009, worldwide. That is 144 months, and if the numbers are consistent that would equal
172,800 complaints, and 14,400 injuries. Things we don't know, only Philips would have this answer. How long for degrading to start, immediately, or several years, or more?

Whatever the case we are talking about a large number of potential medical side effects. 

The obvious question is why have we have not heard of a single incident until now?

How were any previously reported incidents, regardless of the numbers kept secret?      

RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - hegel - 07-26-2021

Btreger, your methodology is flawed and so the conclusions you draw are mere speculation.

You may have missed the rest of my post where I questioned whether all of those complaints will turn out to be related to PR machines. People with health issues will assign all sorts of causes to their troubles; often, they misdiagnose the actual source.

I see no reason to cause unnecessary anxiety. I'll wait for actual research or at least accredited sources using more accurate measurements. Always extrapolating to the worst case seems silly, frankly. In one of the videos put out by a provider that appeared here some pages ago, the speaker said they had had 2 complaints over the years about black particles in PR machines--out of many thousands sold. He wasn't a PR guy, but just trying to assess what we know. So maybe we haven't heard about complaints before now--because there have hardly been any. In other words, there's a chance that news is better, not worse, than we guess or imagine. Maybe we end by breathing a sigh of relief rather than in anguish and despair and anger and grievance.

RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - SingingSam - 07-26-2021

I agree with recent observations that our focus should shift to practical steps that we can take, depending on our circumstances.

This is a newbie post. I'll mostly stick with fresh content followed by commentary that I’ll precede with a warning so you can skip it.

Users like me possibly are a reason why the FDA has labeled this a Class I recall (the most serious type). I've been using PAP for almost 8 years. Although aware of the discussion groups and software, I lost interest quickly. Entirely my fault. I adjusted to ASV quickly, and I got good results. I was blissfully unaware of the recall until an unknown DME emailed me a notice. The DME was my old DME rebranded. Ignorance isn't always bliss, hence the need for the Class I recall status.

If enough people express interest I can start a thread about de-foaming the S1. I've already done the job and took pictures. It isn't difficult. Reassembly is a little tricky. I found a way that I think is easier and produced for me a better result than the utube video method posted by Nick from Australia. I mean that in a nice way. Nick is on our side, and I’m in his debt for showing the way.

In addition, if anyone is interested I can post pictures of two used diffusers with black spots. The environment where my machine is used is neither hot nor humid. I bought the machine new. I've never used anything more aggressive than a clean damp cloth to clean it. Inside my home I monitor airborne particles size 2.5 microns and smaller. I use a combination of exhaust fans (depending on the level of outdoor pollution) and filter fans to keep the indoor particle measure in single digits at bedtime. I quit smoking circa 1988. We never burn candles or anything else. I've done nothing that is known to accelerate the breakdown of the foam. I can't find a plausible reason for the black spots on my diffusers other than the foam breakdown that occurs when the machine is used and maintained as specified. My lungs possibly aren’t as pink as they were 8 years ago.

I wasn't one of the people who complained to Philips or filed a report with MedWatch. I was dumb and happy with my ASV until the recall. I didn't know about the recall until July 9th. Hence my tardiness to the discussion.

My S1 ASV machine is a waste of technology on me. Not my fault. I already owned the machine when a study named SERVE-HF indicated I would be better off with CPAP notwithstanding my complex sleep apnea. So for 6 years the machine has loafed along, reprogrammed to provide CPAP.

After nearly 8 years and over 19,600 blower hours my blower unit is remarkably clean inside. Other than a thin layer of dust on part of the top surface, the foam's condition is good. I drew the foam to scale on a two dimensional CAD system. The size of the foam is about 18.27 square inches. The thickness is about 0-7/16 inches. The volume is about 7.99 cubic inches. The weight is about 1/4 ounce, although my old analog postage scale isn't very precise. It is cut foam, not molded or injected. The foam density is maybe 2-3 pounds. My scales aren't accurate enough to quantify the density accurately. My de-foamed ASV still produces 9.5 cm H20 (confirmed with a digital manometer), and there is no discernible change in the sound. But producing a constant 9.5 isn't hard work for an ASV.  

Rich is correct that simply removing the foam is not a good solution. Among other things simple foam removal blinds OSCAR and SleepyHead to events. I can recognize some events in the Flow Rate Chart. The LCD reports AHI numbers whereas OSCAR and SleepyHead report 0.0. Yes, I know that the machine and softwares use different algorithms to identify events.

What really got my attention was the jump in AHI reported by the LCD this morning. The jump was caused by my changing the System One resistance from 0 to X1. I knew from the size of the jump that there had to have been a dozen or more AHI events last night. Sure enough, even a noob like me can spot some obvious ones in the Flow Rate Chart. I counted 16, and there probably are others I don’t recognize. But SleepyHead and OSCAR both reported 0.0 AHI.

The foam has to be replaced with something in S1 machines. I already have been looking into foam types, starting when Rich posted the warning. ResMed uses polyether urethane foam and silicone foam in their comparable products. True, ResMed doesn't exactly walk on water. But they claim that their foams are safe, and they would be crazy to do so if they know otherwise. I wish we had a chemist or materials engineer chipping into this discussion. It may not even be necessary for the replacement material to be foam. A slab of any stable lung-friendly material of the correct thickness and shape that won't become a host to pathogens may suffice. A slab of medical grade _____. Let's fill in the blank. Who knows, perhaps a 3D printer could produce a safe part.

The balance of this post is commentary.

1. What was Philips thinking in 2009? Polyether urethane (what ResMed uses) has a good track record in medical device applications. It is less affected by water than polyester urethane. And polyether urethane costs less. Polyether urethane has a more open cell structure, which is great for reducing noise. One doesn't have to be a plastics guru to know that something is odd about Philips' choice of foam.

2. Philips recall news is vastly outweighed by covid-19 news. And yet many CPAP users are the same people who are prone to bad covid-19 outcomes. We as a class are picked on. If neither covid-19 nor CPAP deprival kills us, then do you wonder what the next mortal threat will be? I can’t shake the feeling that it is open season on undesirables.

3. What aren't Philips and possibly the FDA telling us about the foam? According to the letter Philips sent to DMEs, the offgassing isn't detectable after a few days if you don't stress the foam with heat, humidity, ozone or UV. A simple filter could handle the particles especially for users like me who use the humidifier only for noise control. Why recall millions of machines when you could give away a starter supply of filters, and then sell millions more at a tidy profit? What happens in the alveoli of our lungs when a 2.69 micron size particle of Philips foam encounters our blood supply? Are we being kept in the dark because we can't understand? Or because we can?

Sorry about the length. I write. I don't edit much.

RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - WakeUpTime - 07-26-2021

(07-26-2021, 04:54 PM)hegel Wrote: ...I see no reason to cause unnecessary anxiety. 

At almost every post, you seem to be protecting Philips best interests.  Of course, it's always prudent to hear both sides of any discussion.  I'm actually not sure how you are impacted by the Philips recall.  How has the Philips Recall affected you personally?  Were you a previous Philips PAP system user and recently forced to purchase another system?  I understand that you were in retail before and perhaps you saw many unusual customer complaints.  I certainly don't have a firm understanding of all the elements of Philips' defective systems and its recall, but I'm content with letting it evolve and will always try to support the best interests of all impacted Philips PAP users.

If there is end-user anxiety, it was indeed created by Philips.  They instructed end-users to immediately stop using their defective devices (unless told otherwise by their doctor), to obtain another xPAP replacement independently (at their own cost), that their devices used faulty foam with a cancer-causing chemical since 2009, etc.  End-users must now do everything to protect themselves given that new information, and always with a firm understanding that Philips has not always provided honest and timely information about its PAP systems.