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+--- Thread: [News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS (/Thread-News-RECALL-THREAD-IMPORTANT-PHILIPS-DREAMSTATION-SYSTEM-ONE-USERS)
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - ST Dog - 11-13-2021
(11-13-2021, 02:24 PM)cathyf Wrote: 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.)
They don't say. What VOC test? Just once or did it also fail a pretest?
What VOCs? In what quantity? how long are they above the limit?
It would also call the DS2 until question.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - HairyReasoner - 11-13-2021
(11-13-2021, 02:35 PM)ST Dog Wrote: 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?
Yes, the one that failed one VOC test was one device of a product not marketed in the United States. But, since it has the same foam as the new replacement units, the FDA has told Philips to have an independent testing company test this new foam.
Philips' testing of the new foam in the devices being marketed in the United States did not indicate this same issue, so thee FDA says it does not at this point have any evidence to indicate the new foam is a problem, but is requiring the additional testing anyway. The FDA is NOT recommending people who have the new machines stop using them. So, it sounds like this is a yellow flag, but not a red one. Of course, yellow flags may turn red with more testing.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - HairyReasoner - 11-13-2021
(11-13-2021, 02:44 PM)ST Dog Wrote: They don't say. What VOC test? Just once or did it also fail a pretest?
What VOCs? In what quantity? how long are they above the limit?
It would also call the DS2 until question.
They haven't released answers to your question. Unfortunately, the report from the FDA For 483 report was heavily redacted. You're right, if the DS2 uses the same foam it would call that into question, but we don't know it uses the same foam (could be likely, though), and the FDA hasn't specifically mentioned any concerns regarding the DS2.
FDA REPORT ANALYSIS - WakeUpTime - 11-13-2021
(11-13-2021, 02:01 PM)btreger Wrote: 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...
Excellent point.
Quote:[FDA, Page 12] "Therefore the Biological Risk Assessment and Health Hazard Evaluation are not adequate because they do not accurately reflect the known data at that time."
There's a lot more Philips internal information that's going to be examined in the months ahead. Embedded in that data no doubt will be evidence that will greatly assist class-actions in how Philips has known much more, and for a much longer period of time than initially disclosed.
Quote:[FDA, Page 13] "Your firm is currently conducting on-going, Class 1 medical device recalls of over 15 million Philips respirator, CPAP and BiPAP devices, due to polyester, polyurethane foam degradation and volatile organic compound emission."
Dreamstation Go - DaveKaye - 11-13-2021
Philips sent me a replacement for my Dreamstation CPAP (a Dreamstation2) but I haven't heard anything about the Dreamstation Go. Has anybody received a replacement for the GO? Is there any news on the Go product?
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Homerec130 - 11-14-2021
My wife just got a letter from Phillips about registering her Dreamstation with Phillips. She has not used the machine in over two years as it no longer suits her needs. It was an ASV machine and she is now on BiPap (old sleep doc said she needed an ASV - current doc says BiPap). Not even going to register it as I can't remember where we stashed it.
RE: Dreamstation Go - btreger - 11-14-2021
(11-13-2021, 11:38 PM)DaveKaye Wrote: Philips sent me a replacement for my Dreamstation CPAP (a Dreamstation2) but I haven't heard anything about the Dreamstation Go. Has anybody received a replacement for the GO? Is there any news on the Go product?
The answer is a simple no. There has been a total blackout of any information on the Go product.
RE: Dreamstation Go - ST Dog - 11-14-2021
(11-14-2021, 11:01 AM)btreger Wrote: The answer is a simple no. There has been a total blackout of any information on the Go product.
I wouldn't call it a blackout, just no specific info just like older PRS1 machines.
I did see a post from someone who got a replacement for their Trilogy ventilator.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - beckysue - 11-14-2021
I had to call and request a replacement manually because my machine was made in the USA but I live in AU. I have not heard a word since that day and it has been over a month now. I have been look over or forgotten about. I give up on getting a replacement ever.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Deborah K. - 11-14-2021
(11-14-2021, 06:46 PM)beckysue Wrote: I had to call and request a replacement manually because my machine was made in the USA but I live in AU. I have not heard a word since that day and it has been over a month now. I have been look over or forgotten about. I give up on getting a replacement ever.
I wouldn't give up yet. Most of us in the US registered back in the summer and have not heard a thing yet. But many have started getting replacements, so there is hope.
