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+--- Thread: [News] PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2 (/Thread-News-PHILIPS-FDA-Update-11-12-2021-Silicone-Foam-Defective-in-DS2)
PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2 - Sleeprider - 11-15-2021
Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
In response to the recall, the FDA recently conducted an inspection of a Philips Respironics’ manufacturing facility to determine what may have caused or contributed to the foam issues and to assess adherence to the agency’s quality system regulations. The FDA inspections are designed to include the review and evaluation of records, staff training, facility operations, medical device production and testing, and the systems in place to ensure product quality. During the inspection, the FDA investigator made several observations that are outlined in an inspection closeout report, also known as a FDA Form 483 This is the FDA inspection report. Read it!
The FDA has requested that Philips Respironics retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. Article and notice here: https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health
So you got your Dreamstation 2 replacement from the recall and thought this was over? Think again! The new Silicone Foam used in the replacement machines has failed VOC testing including carcinogenic and mutagenic compounds of concern. Philips rushed this replacement to production with knowledge the foam in the System One, Dreamstation and Trilogy ventilators was breaking down with potentially dangerous side-effects. Now the problem continues. This well done video by an Australian blogger documents the Philips problem, and argues the new FDA document shows continuing problems with Philips respiratory products. You may want to move as quickly as possible to stop using any Philips product and use the FDA inspection as a basis to argue for a competing product.
RE: FDA Update 11-12-2021 Philips Silicone Foam Defective in DS2 - Jeff8356 - 11-15-2021
Just when you thought things couldn't get any worse.....
RE: FDA Update 11-12-2021 Philips Silicone Foam Defective in DS2 - StratCat48 - 11-15-2021
While Resmed states their silicone foam is safe, has the FDA ever performed an inspection or test to validate Resmed's claim? If the FDA has found the Philips silicone foam questionable, I think I'd be concerned about Resmed's as well.
RE: FDA Update 11-12-2021 Philips Silicone Foam Defective in DS2 - YipeekiOH - 11-15-2021
Nicko at CPAP Reviews did a YouTube video yesterday about the FDA Safety Communication. Not looking good for Philips…and…even worse for users. ?
If you are offended by off-color language…well…Nicko is PO’d and expresses his views in some colorful language.
RE: FDA Update 11-12-2021 Philips Silicone Foam Defective in DS2 - DreamMan - 11-15-2021
I saw in another thread about a poll reguarding people that have been contacted by Philips, received new machines, dates, etc. Maybe their should be a poll entry for people like me who have not heard anything from Philips about my CPAP machine from 5 years ago and my BiPAP machine I purchase in March 2021. How long is the usual wait?
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2 - SuperSleeper - 11-15-2021
My fear is that all of this is going to convince manufacturers to get out of the CPAP-making business altogether.
They may decide it's simply not worth the legal/financial risk of going through such a wide and all-encompassing recall effort... TWO times.
If this silicone based material in DS2 machines is also found to be hazardous, then it might be worth it for Philips to get out of the CPAP machine business completely, and issue cash to recalled CPAP users so they can buy a CPAP replacement from someone other than Philips.
We might very well be seeing the death of the CPAP manufacturing industry. Especially if it's found that ResMed's devices have the same issues. I could see Philips' Respironics division going bankrupt over this.
Of course, that conclusion is premature unless independent testing shows a definite silicone foam hazard in the DS2 units and perhaps in ResMed units as well.
What a mess, indeed.
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2 - zymurgy42 - 11-15-2021
A direct result of manufacturers trying their hardest to make device 'unrepairable', difficult to get into etc.
The 'internal sound baffle' could be a simple swap out - but no.......
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2 - StratCat48 - 11-15-2021
FWIW......
The FDA was aware of Philips intention to market the DS2 as early as July 2020 and from this attached document they should have completed the assessment of safety to approve its release.
The stringent ISO testing is usually, but not always performed by an independent lab. It would be interesting to know if Philips has a facilities capable of the required testing or if they contracted it out. Whoever did the ISO testing would certainly have comprehensive documentation to back up the findings for reports.
The more I learn of government and its agencies, the less confidence I have in their competence.
https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200480.pdf
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2 - StevesSp - 11-15-2021
It is many years since I had any interaction with the FDA, but I will just say that they did nothing to convince me they were solely focused on consumers' health. Rather, it seemed their job was to protect and support large American corporations against smaller competitors and overseas suppliers.
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2 - SuperSleeper - 11-15-2021
I agree with starting a new thread regarding the potential DS2 silicone foam issue. That's really a separate issue from the original DS1 recall.
Also agree that Philips has deservedly damaged themselves in all this, considering they've also tried to shut out end-users from accessing data on their own DS2 machines via encryption. The blame for the original recall, the potential problems with DS2s and the data-encryption can rightfully be laid at the feet of Philips.
What I'm worried about is the net effect upon the CPAP manufacturing industry as a whole. I sure wouldn't want to risk investing in CPAP manufacturing knowing what's going on with Philips and (now) perhaps ResMed and even other companies if this silicone issue is proven to be a real issue.
What would happen if CPAP companies just decided to get out of the CPAP business completely? Ain't no law to prevent that, and I wouldn't blame them if they did.
In fact, DeVilbiss did exactly that only a few months ago. This could be a trend.
That's what's concerning to me - this could only increase the cost of CPAP machines in the future (in order to cover perceived risk for exactly these types of issues).