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

[Horseshoez]

Fun stuff. After over a month of waiting for the sleep lab to send my sleep study results to my doctor, they finally did and my doctor's assistant sent my prescription to a DME, a Few days later the DME called me and confirmed they got the prescription. I told them I would like to receive a ResMed Airsense 10, they told me ResMed canceled their order due to them having so many backorders or w/e. They said the only machine I could get is a Dreamstation 2, but those are back-ordered without an ETA for when they could even get one. So essentially I went through all the hoops for nothing. With the best result being I could get a Crappy DS 2 within the next year.

I expect I'm going to be in the same boat; I'm visiting my ENT today, first appointment with him in 14 years.  I expect he is going to have me do another sleep study and then write me a new prescription so I can replace my 14 year old Respironics REMstarPro M-Series; the question is, replace it with what?  I've called a few local DMEs and they literally have zero inventory.

[mrmagloo]

Guys, this thread is dedicated to information pertaining to the Dreamstation 1 Recall, and only the DS1 Recall. Please make a new thread to further this discussion.

[cbeissel]

Guys, this thread is dedicated to information pertaining to the Dreamstation 1 Recall, and only the DS1 Recall.  Please make a new thread to further this discussion.

The title of the thread includes System One machines as well!

[btreger]

REUTERS

Week Ahead in Health:
Sept. 27, 2021

The U.S. Supreme Court will meet privately for the “long conference,” its first collective review of certiorari petitions since July 1. More than 1,200 petitions have been distributed, among them:

Thursday, Sept. 30

11 a.m. (ET) – The Judicial Panel on Multidistrict Litigation will hear virtual arguments on motions to create MDLs for product-liability lawsuits over models of Philips’ CPAP machines that allegedly produce harmful gases

The cases are In Re: Philips Recalled CPAP, Bi−Level Pap, and Mechanical Ventilator Products Liability Litigation, MDL No. 3014

https://www.reuters.com/legal/litigation...021-09-24/

[btreger]

RE: >above<

BEFORE THE UNITED STATES JUDICIAL PANEL ON
MULTIDISTRICT LITIGATION

In re: Philips Recalled CPAP, Bi-Level PAP, 
and Ventilator Litigation MDL No. 3014

https://aboutlawsuits-wpengine.netdna-ss...motion.pdf

[ST Dog]

GUDID 00606959048720Respironics, Inc. A Series, Sys One, Heater Hum IT1111552 2020-10-26

As a System One user that is interesting.

Wonder what was changed.

---

1. The FDA needs to change the way manufactures can put new products on the marketplace. Today the FDA relies solely on the manufactures own reports. Third-party clinical medical reports need to be summited along with any other paperwork. The manufactures must pay for the clinical reports and cannot pick who does them. 
   

Neither the FDA, FCC, or even the FAA require such independent 3rd party testing.



You think approval takes a long time now, add something like that and it'll double the time.

[btreger]

Neither the FDA, FCC, or even the FAA require such independent 3rd party testing.

You think approval takes a long time now, add something like that and it'll double the time.

If you think the FDA has done a great job regulating Philips machines that is your opinion, which is ok with me.

I never suggested testing every machine, but I think that they have the capability to test a handful of new CPAP machines before they reach the consumer.

If they had done that 10 years ago we would not have had to have this conversation.

[ST Dog]

If you think the FDA has done a great job regulating Philips machines that is your opinion, which is ok with me.

I didn't say that.  But you could claim the same about every drug recalled/taken off the market after approval too.
(though I think many drugs were pulled that shouldn't have been)

I dare say more people have been seriously harmed by those drugs than by the Philips CPAP machines. Even if a few cancer cases are linked to them, it'd be nothing compared with other FDA mistakes.

And how many died on the 737 Max after initial FAA approval? How many billions of dollars lost in the aftermath?

The point is government oversight/approval organizations will never have the manpower/expertise to do stuff like you ask in anything close to acceptable time frames. They already can't do the job they have.

[WakeUpTime]

Has Philips received FDA approvals on the other DreamStation 2 models, beyond the CPAPs and APAPs?  Do approvals for BiPAPs and BiPAP ASVs take longer to obtain, or is it more that Philips is behind in manufacturing them?

Whenever Philips begins their service center foam replacements, it seems likely that the first priority group would be DreamStation 1 BiPAP and ASV owners, unless production and FDA approvals for those DS2 equivalents are imminent, and they'll instead be getting DS2 replacements rather than fixes.  If I'm not mistaken, wasn't that servicing to begin in September?

To Philips' credit, by not providing a timeline for specific devices, they can't be held accountable to a schedule.

[btreger]

The point is government oversight/approval organizations will never have the manpower/expertise to do stuff like you ask in anything close to acceptable time frames. They already can't do the job they have.

I can totally agree with that statement. That is why I recommended a third-party lab, as a Medical University Hospital that is fully equipped and staffed with doctors and scientists who could do this particular job.