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

[b.e.wilson]

Here is the FDA page on using ozone to clean CPAP equipment.  Some significant safety issues from ozone concentrations left in the machine, though not from damage to the materials.

https://www.fda.gov/medical-devices/safe...chines-and

[Ratchick]

Agreed, I think that's the point that most people have missed. This isn't just based on patient reports. It's based on TESTING. That means that yes - they tested in the lab under a variety of conditions - and that almost certainly included in the presence of ozone because otherwise there's no WAY they would have risked saying ozone was a potential exacerbating factor and risk being sued by people like SoClean. Even if they didn't specifically use the SoClean system, they absolutely can replicate it and get results that would at least start to demonstrate a link. But yes, they've also made clear that the ozone "cleaning" products aren't the ONLY reason this might happen, hence the recall.

[btreger]

Mandatory vs Voluntary Recalls

In the United States, if a product is defective and poses a hazard to consumers, the U.S. Consumer Product Safety Commission (CPSC) has the power to request a mandatory recall of the product. A CPSC recall establishes which batch(es) of a particular product is thought to be defective and requires that products from these batches be returned to the maker. Additionally, companies also have the power to initiate a product recall, however, these recalls are referred to as voluntary recalls because the company voluntarily took action without having been told to do so by CPSC.

These days, almost all product recalls are voluntary because it is generally in a company’s legal interest to issue a voluntary recall rather than waiting for CPSC to request a mandatory recall. Despite the fact that recalls can be extremely costly, companies are often motivated to voluntarily recall defective products because doing so is helpful in limiting liability for corporate negligence.

[Ockrocket]

My take so far on all the various input people have given.. 

Ozone cleaners can exacerbate foam degradation, but even without the use of an ozone cleaner PR acknowledge that the foam can degrade and put users at risk.

My machine is 5 years old now, I've stopped using CPAP in September last year and am not going to be using a machine in the future.

Philips Respironics aren't likely to replace or financially compensate us in Australia (and some other countries no doubt).

So I have nothing to lose by pulling my machine apart to see if it shows any sign of the foam having degraded, and if I am at risk of possible related health issues in the future.

I have not used any form of ozone cleaning, and have only (rarely) used mild detergent to clean any components and related accessories of my machine.

I'm crossing my fingers the foam is intact and showing no signs of degradation when I open the machine up. 

[Mark Douglas]

Well, THAT doesn't surprise me. My (industrial chemist) mother did say it was probably that type of foam.

And of course, the ozone cleaning companies would say that - because admitting it publicly would be suicide for them. The fact is that ozone is KNOWN to hasten the breakdown of certain plastics and other materials,..........................

This!   As I have stated up thread of all the things in life to worry about this ranks low.
I was insane pre-CPAP. I was DYING pre-CPAP. OSA put me in divorce court and bankruptcy. 
CPAP literally saved my life.
I refuse to run in circles scream and shout over this.
I will buy another 760 off craigslist for very little money and experiment and practice on it. If the foam is purely for noise abatement out it comes. I run a LOUD Honeywell HEPA room air cleaner for white noise as much as air quality. Most likely CPAP service shops will offer some solution. My machine is 7 years old as I bought it gently low time used so it's cost me $100 a year for my health and sanity.

This is like "covid" inasmuch as it adds excitement the lives of worry warts.

As Jimmy Buffett said "Breathe in, Breath out, move on"

(note to self: make another donation come pay day)

[WakeUpTime]

"...companies are often motivated to voluntarily recall defective products because doing so is helpful in limiting liability for corporate negligence."

That statement speaks volumes as to why Philips announced the recall without offering their customers (DMEs), or the ultimate end-users, any alternative solution.  What's even more dramatic is that they instructed end-users to immediately stop using the recalled Philips systems.

It's rare that manufacturers to do both simultaneously, and in most cases, almost guarantees future significant class-action litigations.

Even though this news has been developing for only a few weeks, the news has really be spreading over the past few days.  Medical centers, hospitals, sleep labs, health industry publications, small local media outlets, etc., are really announcing the news quite urgently and dramatically to their many connected parties.

It's astounding that the response by Philips to end-users, so far, is merely a "Confirmation Number".  There's been no effort by Philips to...

- test that the accuracy of the e-mail address in the recalled device registration
- state the steps the are coming
- state the timetable for follow-up future actions
- state the it's priority 
- state how the process will work for end-users, DMEs, Philips
- state the risks in continuing to use the recalled equipment
- state which systems will be "fixed" versus "replaced" versus "compensated"
- state the degrees to which different users might be impacted (high humidity, ozone cleaning users, machine type and age, etc.)


ZERO COMMUNICATIONS AFTER REGISTRATION


Yet, the response from Philips' CEO was to the investment industry was to say: 

"We discovered a small problem and out of an abundance of caution are getting ahead of the situation." 

I would suggest there are 3 misleading parts of that statement:

(1)  "We" (Philips) didn't discover it through their Research & Development or Quality Assurance departments.  Other people, or other organizations, discovered it.

(2) It actually isn't a small problem for the company (US$600M so far) and not a "small problem" for end-users.

(3) Philips has definitely not gotten "ahead of the situation", except perhaps for the benefit of their legal department.

The interpretation of the Philips' CEO communication seems to mean:

Philips is minimizing their financial impact by spreading the cost of liability over several financial quarters 

(EUR$250 Million in the first quarter, EUR$250 Million in the second quarter, 

and possibly dealing with any class-action lawsuits in the third or subsequent quarters).

Yet the real owners that had been using the Philips recalled products (who ultimately financially compensated Philips for those products) are left without any immediate solution, compensation, or even communications from Philips.  This is a real wake up call to consumers with respect to how some corporations truly regard the ultimate owners of their products.  This may dramatically affect consumer Philips brand loyalty in the future.

Based on Philips response to the recall (so far), the Philips poll has continually suggesting that only about 25% of PAP machine users on ApneaBoard would consider purchasing a Philips PAP system in the future.  If that's an indication of the broader base of Philips users, Philips may be headed for a possible 50% decline in Philips market share for future PAP system purchases, unless they dramatically change their response to the Philips systems recall.

http://www.apneaboard.com/forums/Thread-...hases-POLL

[Mark Douglas]

https://www.webmd.com/lung/news/20210615...nes-recall

"The company will send out updated operating instructions and repair and replace the foam, the company said. Regulatory agencies have been notified."

[DaveL]

My take from reading this:

5. What is the safety hazard associated with this issue? Has Philips received any reports of patient harm due to this issue?
• The recall notification informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions.
Philips continues to monitor reports of potential safety issues through our post- market surveillance activities as required by medical device regulations and laws in the markets in which we operate. "

is that the degrading insulation is within the cpap unit. It's after the filter on the outside shell of the unit. the contaminant is in the airstream that the user breaths.

[canceledcheck]

Another dreamstation user blindsided by this report. I have been using a SoClean  machine for several years. I did call SoClean, since there has not been one peep from the company on the claim that ozone is at least partially to blame. I was told that hey are holding off on a response, getting all there legal ducks into order since their business has basically been destroyed.  Was told that only 20% of all cpap users utilize the ozone machine, so my question is, if they contribute to the problem,  why are all Respironics machines affected. i have loved my SoClean,I believe it did a great job of cleaning, better than I could ever do by hand. I think Philips is slithering in the slimy lawyer world and will blame anybody, anything and the the wrath of God.  Guess the high heat and high humidity here in CO (70 degrees and 11% humidity) are really the problem.
Am also disgusted by all online seller of Cpaps raising their prices by 50%. I find this to be price gouging, which is against the law. I may have to enter the slimy world of lawyers and give these companies a rude awakening.
Good luck to all of us!

[Crimson Nape]

From what I read, the ozone and UV sanitizers exacerbates the foam degradation, but the foam will still degrade, to a slower degree, on its own.

Of the CPAP prices that you are referring to, are they higher than the published list price?