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

[Dog Slobber]

"According to the FDA’s notice, the agency received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown in Philips Respironics’ ventilator devices between April 2021 and April 30, 2022"

That does not mean "led to death".

[btreger]

"According to the FDA’s notice, the agency received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown in Philips Respironics’ ventilator devices between April 2021 and April 30, 2022"

That does not mean "led to death".

Please tell all of us what you think this means.

[pholynyk]

Association is not causation... Two events occurred at about the same time... They were using a foamy Respironics machine, and they died... We are not told why they died, so we should not assume the foam caused the death.

[btreger]

Association is not causation... Two events occurred at about the same time... They were using a foamy Respironics machine, and they died... We are not told why they died, so we should not assume the foam caused the death.

I can live with that explanation. Hopefully, we will get an undeniable report one way or the other one day. Like a Recall or a Class Action Law Suit.

[TimaaaaaaaahRocks]

Association is not causation... Two events occurred at about the same time... They were using a foamy Respironics machine, and they died... We are not told why they died, so we should not assume the foam caused the death.

Fair to say huffing plastic particles was not good for them?

We know that inhaled plastics can produce inflammation and lesions in lungs, and repeated exposure is suspected of leading to respiratory problems like asthma and cancer. Inhaling plastics may also increase exposure to other toxic substances and coatings associated with plastics and their manufacture.

These machines were meant to provide treatment for a disease. Instead they pummeled particulates under pressure into patient's lungs. And they knew about it for years and failed to act. Classy move. *golf clap*

[btreger]

RE: MasDevice Article I Posted on 05/20


FDA says Philips ventilator recall produced over 21,000 device reports, 124 deaths

Yesterday we went through a number of posts regarding the meaning of the wording in the article, " Association is not causation ".

I decided not to continue this discussion online, but to reach out directly to the FDA and the Editor of MassDevice via e-mail and asked for more clarification on the overall meaning of the article.

This is the response I received from the FDA:

We agree that there is a difference between associated with and actual causation. Reports of adverse events, including deaths, are often difficult to determine causation from the reports themselves and, as in this case, require additional information and analysis, if feasible. We felt it was important to share what information we had at this time with the public understanding that we are continuing our investigation, information gathering, the performance of studies, and analyses. As we noted, this is information Philips had generally not provided to us beforehand.

Dr. Jeff Shuren

[DaveL]

Thanks for your post Dog Slobber.
Thank heaven I don't have a Respironics machine; though I had two of their bricks in the past.

My sleep-doc-from-h?ll told me if I was non compliant it could kill me.
He didn't tell me that Respironics, the make of machine he prescribed would kill so many people identified in this post. 124.

[Vice]

How long have these machines had this foam issue. Here is a YouTube guy that breaks down a machine from the 90s  00s with degradation issues.

H ttps://youtu.be/2M8yKA5tyOU

[Dog Slobber]

Thanks for your post Dog Slobber.
...
He didn't tell me that Respironics, the make of machine he prescribed would kill so many people identified in this post.  124.

Could you please quote the statement within the article supporting your allegation the respironics machines killed 124 people.

[DaveL]

"According to the FDA’s notice, the agency received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown in Philips Respironics’ ventilator devices between April 2021 and April 30, 2022"

That does not mean "led to death".

I'm sorry if I interpreted this wrong.

Could it mean:

either==124 died due to the foam issue

or==124 died of sleep apnea while using this medical device?

Rather than be concerned, I shall just be grateful that I have a ResMed machine. To the best of my knowledge they aren't recalled.