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

[btreger]

See my post above -  I agree with you.  

But that said, it does not prove that no clinical testing was done.  It simply means that no clinical testing was required for clearance.

Your right, but no one knows except Philips what they did or did not do back then. What we do know is that when they went back this spring and did do some testing they found, out of nowhere the foam problem, go figure......

[glenlyon602]

It was reported that the  recall was due in part to the company having reviewed the results of two studies, reportedly done in 2011 and 2014.

Can someone on this forum point me to the studies mentioned?

Thanks.

Hello, WSH.

I had mentioned this in post #774.  If you look upthread at post #721, there is a link to a video by an on-line vendor of CPAPs.  At 10:52 of the video, he shows an image of a recent report issued by Philips to doctors and DMEs.  The bibliography page on the screen (stop your video to read it) shows the report's footnotes 3 and 5, dated 2011 and 2014.  If you go back in the video to other pages from the report, you can see where those footnotes 3 and 5 are cited.  They are basically the places where Philips says it noticed the problem.

Philips mixes up their words like a salad, and these references are mixed in with sentences about their internal and independent (& I assume paid-for) studies of the CPAPs. But their awareness of the problems goes back to those articles.

I spent some time trying to find the articles and the journals they were in, but didn't get far.  I assume Philips knows they are good research or they wouldn't have taken their subsequent actions.

I cannot find this report online; all I can see on the Philips website is the first "Clinical Information" report dated 14 June 2021, very vague.   When you see the report in this video that this vendor is looking at it, it has a different title page, and seems much more specific.

Would be interested in your view of this.

[racprops]

I screen captured all of the pages in this report.

Here is the page you cited.

[attachment=33952]

[racprops]

I read the reports, and they seem to cite some testing of the foam.

They DO NOT seem in my opinion to be a smoking gun, as we do not see the results of these tests.

For all, we know they may have passed these tests.

Also, the first line is: " 1) 486 Foam-related complaints in 2020 for 1.56million devices shipped in that year representing a complaint rate of 0.03%"

Sad to say it may very well show they were doing the right thing and testing the product for what happened and found no problem in any of these tests, we really need the findings of these tests.

Rich

[WakeUpTime]

Also, the first line is: " 1) 486 Foam-related complaints in 2020 for 1.56million devices shipped in that year representing a complaint rate of 0.03%"

For many reasons, 486 foam complaints in 2020 is a very large number to me:

- 486 complaints (within 12 months) likely came from those that had large enough foam particles appear, and likely having it occur many times, not just once.

- If I had a speck of foam in my humidifier or mask every morning, I absolutely wouldn't notice it during washing.  Besides, I wouldn't wear reading glasses when washing my equipment.

- People that had extremely small particles of foam disintegrate, and not get stuck in their mask to be visibly noticed, didn't complain.  So Philips is implying it's "safe" for everyone else then.  Only a few kids got sick from drinking Detroit's drink water several years ago.  That didn't mean that everyone else had clean drinking water.

- Is complaining to Philips a simple procedure?  Likely not.  An official device complaint perhaps might only be allowed through an authorized DME, on behalf of an end-user perhaps.

- If your car manufacturer, e.g. Tesla, had only a 0.03% complaint rate of their cars catching fire, that wouldn't be very good.  That would be 150 Teslas catching fire from each model year, every year.

Everyone should try counting up to 486, and at each number, imagine how bad their situation had to be before they were successful in registering their official complaint with Philips (in just 2020 alone).  I wouldn't worry if 3 people complained.  At 486 complaints, I'd be pretty sure that I breathed in some particle of foam (no matter how small) on some occasions.  But there would be many that would say "that's nothing".

There's a simple way to know how much foam we have ingested:  scientifically measure our current defective foam in our sealed systems, rather than having Philips secretly dispose of it during their refurbishment process.  Philips would never willingly allow that.  

For the recall process to be truly effective, a federal health agency

should be analyzing samples of recalled system foam returns

for their weight and composition.  

The resulting data would have both integrity and significance.  Perhaps it will state that the average foam sample lost 18% of its original weight, that recalled device users ingested.  Perhaps it would state that there were several samples of foam returns that lost up to 50% of their original weight.  That real-life data would be useful in determining possible long-term health consequences.  If a federal health agency won't do that, then a class-action law firm should argue for an independent analysis agency to do that.

[btreger]

I read the reports, and they seem to cite some testing of the foam.

They DO NOT seem in my opinion to be a smoking gun, as we do not see the results of these tests.  

For all, we know they may have passed these tests.

Also, the first line is: " 1) 486 Foam-related complaints in 2020 for 1.56million devices shipped in that year representing a complaint rate of 0.03%"

Sad to say it may very well show they were doing the right thing and testing the product for what happened and found no problem in any of these tests, we really need the findings of these tests.

Rich

Hi Rich,

Some factors to keep in mind;

 - Once the FDA gives a manufacturer Clearance to go market with an updated product line there is no requirement that they have to submit ongoing Clinical Testing results

 - It is assumed that most consensus companies would be doing ongoing testing and monitoring throughout the lifecycle of their products, but this would be only internal within the company

 - This is the important part. Philips knew from the very beginning of product development what Foam they would be using and all the health risks it could pose. They proceeded without any disclosure of this information. Only when a significant number of users started complaining of various systems, mostly respiratory, they knew they had to act before the FDA issued a mandatory recall.

So they created this scenario of doing internal testing, they already knew what they would find, and issued an involuntary recall. My guess is that they went to the FDA prior to the recall, and asked for their help to resolve all the problems that were starting to come out.

Without that FDA involvement, Phipips would be left on their own, dangling in the wind.     

[hegel]

Your Important Part is mere speculation written as if it were fact--as if it had happened. But, again, it's merely your speculation.

I could just as well write up "Philips did a series of thorough tests that cost millions of dollars and found no reason for concern". That sounds like fact; it's not. It's speculation.

I think it's important to write responsibly and try to stay with factual parameters on this issue. We don't know a lot.

[Dog Slobber]

 - This is the important part. Philips knew from the very beginning of product development what Foam they would be using and all the health risks it could pose. They proceeded without any disclosure of this information. Only when a significant number of users started complaining of various systems, mostly respiratory, they knew they had to act before the FDA issued a mandatory recall.

Citation needed.

[btreger]

Your Important Part is mere speculation written as if it were fact--as if it had happened. But, again, it's merely your speculation.

I could just as well write up "Philips did a series of thorough tests that cost millions of dollars and found no reason for concern". That sounds like fact; it's not. It's speculation.

I think it's important to write responsibly and try to stay with factual parameters on this issue. We don't know a lot.

We do know a lot, we have spent just over a month obtaining information that is all available in the public domain and has been previously posted on this thread. So this was not speculation. When I did not have those specific facts but had facts that would suggest a specific conclusion, I used the term I guess these conclusions. 

I do not think that covering for Philips, or offering doubts about their contempt for human life is very welcome on this thread, where so many people have been affected by their behavior.

[hegel]

I'm not covering for Philips. I'm pushing back on unsubstantiated claims. Rumors written as if they were established fact.

I don't know that people who work for Philips hold human life in contempt.

I'm suggesting that random people voicing opinions on the internet who brook no disagreement with their opinions are not the best sources for information on this important issue. Or other issues. I'm calling for reasonable, fact based discussion.