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[News] PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
#21
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
While on the one hand I have zero trust for PR and an even lower opinion of their competence, I also think that a VOC problem is probably inherently less serious than the foam disintegration problem. The VOC issue is most likely a "new car smell" problem, and self-limiting in that once the plastic outgasses the small amounts of VOC that are there, it's done. With the foam disintegration, once it starts it keeps breaking down. With VOCs it's small impurities in something that is otherwise safe, as opposed to the entire piece of foam breaking down and becoming part of the problem.

You know the world isn't a completely sanitary place, and we are all breathing in a certain amount of crud all the time. Unless there is some subtlety I'm not seeing, this doesn't sound as serious. It sounds like the FDA is being a little overcautious because they don't trust PR, as opposed to them being pretty sure that there's a problem.

If this is about some small amount of manufacturing impurities, it might be worthwhile to turn the machine on and run the blower for a couple of hours before first use. If you've already been running it for awhile, it's probably too late as the VOCs are probably gone already.
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#22
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
I don't agree with the view that this could frighten companies from the CPAP industry.  I think the opposite is the case.  This industry is a goldmine.
Better machines than these are well within the capability of any number of companes to produce with today's technology.  Furthermore, keeping materials which emit harmful vapors out of the air path is not 'high tech'.  It's simple - a no brainer.
What's actually happened is that CPAP manufacturers have been laying golden eggs for, like, forever - in an incestuous relationship with an ineffective, incompetent and corrupt FDA and similar agencies.
Many companies could produce better devices (and better masks, too) quite easily, and make them safe for us users, at a much lower price, if not for the general corruption of the medical industry.
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#23
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
(12-26-2021, 02:57 PM)cronkster Wrote: I don't agree with the view that this could frighten companies from the CPAP industry.  I think the opposite is the case.  This industry is a goldmine.
Better machines than these are well within the capability of any number of companes to produce with today's technology. 

Sure plenty could design and produce machines.
But getting them approved is another matter.

The regulatory red tape is a huge barrier to entry and an even bigger strain ongoing.
it's not like copying some basic appliance or general consumer device.

Companies have been leaving the market. Why do you think that is? Because of the huge profits on a cheap, easy go make device (your gold mine)?
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#24
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
Those are good points.  But so are mine - I'm not the guy you should be arguing with
Neither the clunky, slow moving and expensive FDA process or the medical industry or the manufacturers are doing a good job. Yes, companies are leaving the space.....bad companies.
A company who is on the ball could put out a much better machine quickly  - then all that would be left is waiting for the FDA, which should now have a fire under its butt to get something approved. There is opportunity.
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#25
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
While Philips tries to pay a lab to somehow come up with tests that can claim that there are no VOCs off-gassing from the new silicone foam, I made a slight tweak to the airpath of the DS 2 they sent me.
I modified one of the little activated charcoal sachets that are used with my water distiller, made it smaller and with less granulated charcoal in it so as not to cut down on the airflow.  I placed that into the inlet port (the bottom one) of the humidifier so any VOCs in the airflow might adhere to the charcoal.  The machine still seems to work fine and be just as quiet.
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#26
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
(01-04-2022, 07:34 PM)cronkster Wrote: While Philips tries to pay a lab to somehow come up with tests that can claim that there are no VOCs off-gassing from the new silicone foam.

They don't "come up with" tests, they are specified by international standards.

There has never been a claim of no off gassing. The issue is how much of what and for how long.
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#27
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
Ha !  Dream on, Dreamstation user.
As if the FDA is trustworthy in enforcement, Philips doesn't have incentive to cheat, companies don't cheat regularly, or any level of VOCs in the airpath is safe or necessary.
Those who think that VOCs are safe and believe what they're sold, feel free to suck that CPAP air deep into your lungs.
Anyone sensible enough to be sceptical can check out Roe Rogan's recent interview of Dr. Robert Malone for more on the general topic of whether to trust the FDA, large companies that it deals with, or the medical establishment.
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#28
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
If anyone has actually received a new machine Did phillips want the old machine back? Did Phillips inspect the old machine prior to the consu,er getting a new machine. I searched for an answer but could not find it TIA
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#29
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
@ Feedsack....
Received a new DS2 in October (had submitted DS1 registration in July). Still had the DS1 at the time I received it.
Yes they wanted the DS1 back so it could be refurbished and sent to those who required a DS1 replacement. No pre-inspection of the DS1 before they sent the DS2. Philips provided a return shipping label.
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