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

[btreger]

The Legal Examiner


What Injuries Have Been Caused By Philips CPAP machines?

Why Is the Foam From Philips CPAP Machines Toxic?

The foam that suppresses noise can spur potentially serious or life-threatening illnesses on Philips CPAP users. Polyester-based polyurethane (PE-PUR) forms the essential foundation of the foam. With the breaking-down, or degrading, of PE-PUR come small particles and gasses that the sleep apnea patients ingest or inhale while using the CPAP. The chemicals in these gasses and other matter include isocyanates. Below, we’ll discuss the potential adverse effects of degraded PE-PUR.

Bacteria and fungi represent catalysts for degrading polyester-based polyurethane. Often, these microorganisms take hold in constantly-used and sparsely-cleaned or maintained CPAP masks and airway tubes. To kill the bacteria, some users may turn to ozone-based cleaners. Doing so simply replaces one agent for breaking-down PE-PUR (microorganisms) with another (ozone). Humidity and high temperatures also constitute culprits for releasing the gasses and particles from PE-PUR.

What Injuries Have Been Caused By Philips CPAP machines? (legalexaminer.com)

[TimaaaaaaaahRocks]

Why Is the Foam From Philips CPAP Machines Toxic?

Because it says so in the Material Safety Data Sheet?  

I suspect law firms have done more product integrity testing on PR devices than PR did for their 510Ks.  

---

https://www.expertinstitute.com/litigati...-toxicity/

Polyester-based polyurethane (PE-PUR) foam is ubiquitous across industrial products. PE-PUR foam is largely used for its low density and sound insulating properties. For these reasons, polyurethane foam is often employed on sleep and respiratory care devices. PE-PUR foam is also a type of polymeric foam, belonging to a family of similarly lightweight, high-strength foams. But this foam is currently under scrutiny after a product recall from Dutch medical equipment company, Philips. In June 2021, the company voluntarily recalled several models of ventilator and CPAP machines. It cited evidence of the PE-PUR sound abatement foam degrading into particles that users could potentially inhale. Since PE-PUR foam contains isocyanates, a highly toxic chemical class, this recall raises patient safety alarm bells. For attorneys pursuing PE-PUR foam-related cases, here’s what you need to know about foam toxicity and the ongoing recall.

Diethylene glycol (DEG) is among the chemicals released by PE-PUR foam on Philips devices. DEG is a highly toxic, colorless, odorless chemical. It’s often used in antifreeze, brake fluid, and lubricants. Exposure to diethylene glycol can have severe effects. Health complications range from nausea and vomiting to coma or even death.

[cathyf]

Diethylene glycol (DEG) is among the chemicals released by PE-PUR foam on Philips devices. DEG is a highly toxic, colorless, odorless chemical. It’s often used in antifreeze, brake fluid, and lubricants. Exposure to diethylene glycol can have severe effects. Health complications range from nausea and vomiting to coma or even death.

At least in my head, I was making a distinction between two things.

First the VOCs of the "new car smell" class, where everything new will outgas small amounts of residual solvents left over from manufacturing, solvents left on surfaces. These would be trace amounts that outgas until everything evaporates off -- which is on the order of a couple of hours to a couple of days.

Then there is the long term (months/years) gradual breakdown of foam, which sends foam particles of all sizes down the hose. The big ones you can see are not as dangerous as the tiny ones, since our lungs are constantly inhaling small particles of dust, etc., and we have mechanisms (coughing, "throat clearing", mucous trapping, etc.) which are designed to clear these.

But this is bringing up a third thing that I didn't appreciate at all until now. Which is that as the foam breaks down it generates new surfaces, which chemically react, and a steady supply of new VOCs are produced.

(This is actually why the ozone cleaners freak me out. Ozone is incredibly reactive, and so this becomes a continuous chemistry lab experiment where the components of the machine AND the continuously changing low levels of whatever crud floats around in the air in your home are reacting with the ozone and then the reaction products are reacting again.)

[TimaaaaaaaahRocks]

First the VOCs of the "new car smell" class, where everything new will outgas small amounts of residual solvents left over from manufacturing, solvents left on surfaces. These would be trace amounts that outgas until everything evaporates off -- which is on the order of a couple of hours to a couple of days.

The "new PR cpap smell", just imagine what the PR production line might smell like? OSHA regulates workplace exposure to VOC and semi-VOC compounds like isocyanates. Considering PR failed to protect patient safety it is not a stretch to imagine they don't give a rat's dupa about production employees. 

From OSHA: "Health effects of isocyanate exposure include irritation of skin and mucous membranes, chest tightness, and difficult breathing. Isocyanates include compounds classified as potential human carcinogens and known to cause cancer in animals. The main effects of hazardous exposures are occupational asthma and other lung problems, as well as irritation of the eyes, nose, throat, and skin."

At the same time, some of the nastiest compounds released by disintegrating PE-PUR foam are highly toxic AND odorless. 

Anyone working around these machines should consider getting tested for the specific compounds released by the PE-PUR.

[SleepyCPAP]

Q&A That I found online, check out the date:

Zhang Yee
Date: 7/28/2019
When I wake up in the morning there are small bits of black greenish colored material in the humidifier chamber. My machine is only 1 year old and I am worried about breathing it in. What do you think it can be and why is it happening? 
Advans CPAP Staff
Date: 9/11/2019 5:26:00 AM
Those bits may be foam insulation that has deteriorated inside the cpap machine. Typically caused by cleaning devices that uses ozone to disinfect the unit. Unfortunately, the ozone breaks down the insulation and rubber seals inside the unit over time. The foam will be sucked into the motor and damage it.

[WakeUpTime]

CPAP Staff (Garden Grove, CA)
Date: 9/11/2019
The foam will be sucked into the motor and damage it.

Good additional evidence.  If the DME was aware of the problem in 2019, Philips likely knew of the issue long before 2021.  Philips' dealers could also be very credible witnesses to the longevity of the problems associated with the deteriorating foam.  One would think that the FDA would be talking to them as they would be much closer to the end-users.

It's interesting how the DME was extremely careful not to point out that the foam particles had also likely been inhaled by the Philips device user.  I wonder if the end-user made the connection.  It's likely that the incident ended there.  In a more perfect world, a report would have been forwarded by the DME to Philips, and the end-user would have issued a complaint to the FDA or local health agency.

P.S. I just searched the text of that response and indeed found that end-user's question and the DME's response.  We should forward that link to the class-action legal staff as additional evidence.  I'll probably do that in the morning, but I'll make a printout of it now just in case Philips' legal department uses its might to have that DME comment removed.

[btreger]

FDA considers another Philips ventilator recall serious

JANUARY 27, 2022 BY SEAN WHOOLEY

The FDA has identified another recall at Royal Philips‘ (NYSE: PHG) Respironics business as Class I, the most serious kind.

FDA said in a notice that the reason for the recall again centers around the PE-PUR foam, with lab testing of the Trilogy Evo identifying the issue. Ventilators with non-conforming foam were distributed to customers in the U.S. and Korea, but the company has reported no injuries or death to date.

Affected devices were manufactured and distributed between April 15, 2021, and May 24, 2021. To date, 215 ventilators and 51 repair kits have been recalled in the U.S.

FDA considers another Philips ventilator recall serious - MassDevice

[btreger]

RE>My above post<

By now we all got to be asking the same questions;

Wow, what a surprise (not). The thing is they are not stupid. They know exactly what foam is in every machine they ever made. Why wait for the FDA to discover it?

[TimaaaaaaaahRocks]

The thing is they are not stupid. They know exactly what foam is in every machine they ever made. Why wait for the FDA to discover it?

Right? Like the foam is unsafe in this machine, but not in this machine. Trying to split hairs, or trying to save a few thousand on a billion dollar plus problem? That is actually stupid. PR may employ a bunch of people who are not stupid, but somehow you put them all together and you get stupid results that have endangered their end-customers. 

PR obviously has a safety and regulatory culture problem. How else could you explain shipping millions of defective products. The Product Verification and QA departments are broken. Otherwise they would have been on top of this foam fiasco after the first complaint many years ago. Mr Mell is not stupid. As head of quality he is certainly aware the FDA has very specific regulations concerning how to handle internal test results, field complaints, and corrective actions. The QA department must be getting direction from some really ignorant upper management. How else could you explain QA's culpability, 'they didn't know' just doesn't seem plausible. I expect we'll get more color into the PR culture of stupidity if and when the class action suits get to court. Maybe sooner if the PR response to the 483 becomes public. 

Attorney: Mr Mell can you please tell this court why your company ignored many of the sections in Title 21 of the United States of America's Code of Federal Regulations?

[meetra]

Hello everyone,

I see that there are already some legal action in Belgium and the Netherlands against Philips: https://www.brusselstimes.com/belgium-al...a-machines

Does anyone know of other legal actions in Europe?

Thanks!