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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: PHILIPS AND THEIR PERCEIVED "SHELVED" DEVICE OWNERS
(11-12-2021, 11:34 PM)WakeUpTime Wrote: …..The only way that Philips could possibly consider a device as "shelved" is that updated device data is not being uploaded to the Philips cloud.  
…..

I understand what you are saying, but SystemOne users like me are part of the recall and these machines have never (to my knowledge) been connected to the Philips cloud.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines
November 12, 2021


Today, the U.S. Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines.

https://www.fda.gov/news-events/press-an...ovdelivery


FDA Form 483  ( inspection closeout report )

https://www.fda.gov/media/154099/download
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RE: PHILIPS AND THEIR PERCEIVED "SHELVED" DEVICE OWNERS
(11-13-2021, 02:15 AM)cbeissel Wrote: I understand what you are saying, but SystemOne users like me are part of the recall and these machines have never (to my knowledge) been connected to the Philips cloud.

Not directly. Only if you used the app that downloads data from machine and uploads it to your account on their server.

At least that works with my Bluetooth enabled machine. 

And I'm not sure if all the DreamStation machines came with cellular modems. I though I read that early on it was an optional add on.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(11-13-2021, 09:30 AM)btreger Wrote: Today, the U.S. Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines.

https://www.fda.gov/news-events/press-an...ovdelivery

Seems the FDA is being wishy-washy on the new foam now.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(11-13-2021, 10:01 AM)ST Dog Wrote: Seems the FDA is being wishy-washy on the new foam now.

You might want to read the other link;

FDA Form 483  ( inspection closeout report )

https://www.fda.gov/media/154099/download
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LATEST FDA RESPONSE (NOV-12-2021)
(11-13-2021, 09:30 AM)btreger Wrote: FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

(11-13-2021, 12:43 AM)Phaleronic Wrote: Update from the FDA

Those are great documents (the news release and the associated report) and worthy of being added to the Recall Wiki.  For those that are keenly interested in the Philips-FDA safety issues related to the recall, it's a must read.  
Thanks for posting!

Legally speaking, has the FDA taken the legal and financial burden off many parties (users, insurance companies, agencies, DMEs, etc.) as a result of officially making the directive that ALL recalled device owners should just continue using their recalled devices until a replacement solution is found?

As an analogy, isn't this a little like what happened a few years back with Michigan advising Detroit-area residents to continue drinking their bad water, perhaps along with a light-duty water filter - knowing that they couldn't instantly provide ALL affected residents with an immediate safe solution?  In other words, it's fine to suffer potential long-term consequences as we can't instantly eliminate everyone's problems associated with the faulty foam in their medical devices.

Now, all affected parties can state that the FDA publicly stated that it's safe to continue using the faulty-foam devices for however long it takes for users to obtain a replacement.  Since the FDA has NOT themselves done long-term testing of the faulty-foam device testing under various conditions (pressures, device-types, various cleaning solutions, altitudes, temperatures, etc.), their all-encompassing advice to continue usage is extremely faulty (in my opinion).
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: >above<

What stands out to me is in the "Inspection Closeout Report'

On page 12 of that report, it shows Philips was made aware of foam degradation from 01/01/2008 through April 2021 across all products that contained polyester polyurethane foam.

I think that is called a smoking gun...

https://www.fda.gov/media/154099/download
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(11-13-2021, 02:01 PM)btreger Wrote: RE: >above<

What stands out to me is in the "Inspection Closeout Report'

On page 12 of that report, it shows Philips was made aware of foam degradation from 01/01/2008 through April 2021 across all products that contained polyester polyurethane foam.

I think that is called a smoking gun...

https://www.fda.gov/media/154099/download

I put the report through OCR, and here's the smoking gun the btreger is talking about:

Quote:Alternatively, a query of your firm's consumer complaints from 01/01/2008 to current, for the keywords
contaminants, particles, foam, debris, airway, particulate, airpath, and black, resulted in over 222,000
complaints, and over 20,000 of which occurred between 2008 to 2017 and involved Trilogy devices.
Additionally, your firm performed a foam related complaint data analysis in April 2021 on complaints
confirmed to be related to or involve foam degradation issues. The raw complaint data documents that
30 Trilogy related complaints were received from 2014 to 2017, and 1,254 related complaints were
received across all products containing the affected foam, from 2014 to 2021. Therefore, this Biological
Risk Assessment and Health Hazard Evaluation are not adequate because they do not accurately reflect
the known data at that time.

"...do not accurately reflect the known data at that time."

They knew.

So the foam complaints started coming in 2008. Of course it's not reasonable to say "should have known" after just the first few complaints, but even reading this in the way that puts PR in the best light they certainly knew by 2018.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Another tidbit:

Quote:During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a singular, similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called Volatile Organic Compounds.

The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. At this time, the agency does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S.

Am I reading this correctly that the NEW foam that they are using to repair machines with is now suspect?

Is this new information? Is this a reason to be concerned about all foam in all machines? (The subject of VOCs is controversial, because when you are talking "new car smell" those VOCs might dissipate very quickly and not be a real risk.)

Do we know if the ResMed foam is the same as the "silicone-based foam" in question?
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(11-13-2021, 10:21 AM)btreger Wrote: You might want to read the other link;

FDA Form 483  ( inspection closeout report )

https://www.fda.gov/media/154099/download

It's on my to-do list. 

But the initial summary, and the news reports all make it sound like one other device, not used in the USA,  had an issue. But us that the only similar device, it just the only one with a rest failure?
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