RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
The New York Times
The following article would not normally be posted here. Except it mirrors the history of the Recall so closely, that we all can relate to the failings of the FDA and the repercussions of those failings. Just substitute food safety with medical devices.
Lead-Tainted Applesauce Sailed Through Gaps in Food-Safety System
Hundreds of American children were poisoned last year. Records show how, time and again, the contamination went unnoticed.
Hundreds of pages of documents obtained by The New York Times and the nonprofit health newsroom The Examination, along with interviews with government and company officials in multiple countries, show that in the weeks and months before the recall, the tainted applesauce sailed through a series of checkpoints in a food-safety system meant to protect American consumers.
Time and again, the tainted cinnamon went untested and undiscovered, resulting from an overstretched F.D.A. and a food-safety law that gives companies, at home and abroad, wide latitude on what toxins to look for and whether to test.
“It’s amazing in a bad sense what a catastrophic failure this was,” said Neal Fortin, director of the Institute for Food Laws and Regulations at Michigan State University. “Largely, the food supply regulatory system is based on an honor system.”
Lead-Tainted Applesauce Highlights Failings in Food Safety System - The New York Times (nytimes.com)
02-28-2024, 08:12 PM
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Good thing I don't put applesauce in my DreamStation's humidifier chamber.  
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
$479M Phillips Respironics Devices Recall Class Action Settlement
The Final Hearing in the Court to grant settlement approval is scheduled for April 11, 2024. Court dates and deadlines are subject to change so please check this page regularly for potential updates.
$479M Phillips Respironics Devices Recall Class Action Settlement (openclassactions.com)
03-11-2024, 05:16 PM
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Finally got a ResMed AirSense 10 Autoset, since I realized that my private insurance covers it, unlike the gov't insurance. I got the 10 instead of the 11. Did I do good? Opinions?
I got the modemless one, because, well, it's modemless. I got it all set up via the clinician's menu. The only quibble I have about it is that the AHI doesn't display in the patient menu like for the Elite I had been using, so I have to employ the secret handshake to go see it in the clinician's menu each time I want to see the AHI directly on the machine. No biggie, because I inserted my trusty old Toshiba FlashAir SD card (pity it's discontinued) and can wirelessly access all the data via FlashPap.
The huge upside, of course, is that I can take the DreamStation, even the new & not improved one they finally gave me, offline for good.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
FDA
The FDA hosts the International Medical Device Regulators Forum
The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH)
Note: Dr. Shuren leads the FDA in the Philips Recall response and investigation
Our mission has not changed in 13 years – we share the vision that we can positively impact the health and quality of life of many people when we align on policies, standards, and practices.
By building trust through the sharing and protection of information and expertise, regulators may rely on the pre-and post-market decisions of other jurisdictions, which can save significant time and resources.
One of the core principles of IMDRF is that our work should be available to all. Our working groups develop technical guidance and other documents to provide policies and best practices to the entire medical device community.
CDRH Welcomes 25th Session of the International Medical Device Regulators Forum | FDA
03-17-2024, 09:34 AM
(This post was last modified: 03-17-2024, 10:07 AM by btreger.)
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Pittsburgh Post-Gazette
Safety concerns emerge over breathing machines at another Pennsylvania medical device maker
Drive DeVilbiss Healthcare abruptly stopped making the machines at its Somerset facility in 2021
Months after Philips Respironics launched a massive recall of its breathing machines fitted with an industrial foam capable of spewing dangerous particles and fumes into the lungs of patients, another device maker just 60 miles away fired off a letter to customers that it was abruptly dropping its popular machines.
Drive DeVilbiss Healthcare said the news was "unfortunate short notice." Still, it would no longer be making its sleep apnea devices after delivering them to customers for decades from its sprawling facility in Somerset.
The company's CEO blamed a shortage of parts driven by the pandemic and hurdles in obtaining electronic chips as the reasons for ending the sales of what was once one of the company’s signature devices.
However, what was not disclosed in the letter was that the DeVilbiss machines were filled with the same type of foam as the Philips devices. This material can degrade and release volatile organic compounds, including formaldehyde, into the noses and mouths of users.
Safety concerns emerge over breathing machines at another Pennsylvania medical device maker | Pittsburgh Post-Gazette
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Executive summary:
The lawyers said, "Shut this suable operation down pronto and blame the pandemic."
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
It just goes on and on.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
just FYI (a very belated story, but may be useful to some) -- Philips first refused to replace my old System One 950P ASV, they wanted me to ship it to them (at my expense) and send me a $25 check after... I complained, then they realized they wouldn't want me to keep using it, so they agreed to replace it, and they gave me a Dreamstation ASV after I returned the old machine
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
We've given up on a proper resolution. If it occurs, we will consider it "Found Money" at this point. Currently, we're stuck with a nearly new DS2, a refurbished DS1 and a pair of DS Go units. Originally, we opted for replacement on every DS1/GO unit. We were only halfway home when the conveyor belt stopped and another issue surfaced, formaldehyde. Currently, we have a pair of ResMed AirSense 11 AutoSet units inbound. We will deal with the travel units when we recover from this stage of replacement. What a hot mess!
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