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

[Helena]

Helena, ... please "Edit" your above post to include only a minimum of details from the quote that you're replying to.  ...

I apologize. Sorry I missed the editing deadline. I will be more careful.

[WakeUpTime]

...

Philips may never detail their precise device replacement plan publicly, leaving them with the most options.  The recall spans many countries too.  We're fortunate to have ApneaBoard and this specific thread to detail what (when, and where) specific devices are getting replaced.  Later, they'll be much talk too about the "why" for each category.  Philips may not appreciate us publicly discussing those revelations in the future.

[mrmagloo]

We do know that they will never be able to manage discriminating on a granular level to an individual, so at some point the master plan will be fairly evident. To your point, just member feedback here will present a pretty clear overview. But again, at this point we know nothing.

The good news is, it does seem they are actually trying to conjure something up instead of blaming the FDA.

[Sea Papper]

The FDA doesn't seem to be happy with Philips communications to patients regarding the Philips Recall.  They've made it a major discussion topic at their next FDA Conference in October:

Big whoop. The FDA was aware of DS complaints for years and did nothing. The FDA was aware that RESP knew about the non bio-compatible foam problem for years and did nothing. RESP warned investors in April 2021 that some bad stuff was coming but didn't bother to warn people huffing foam particles and VOCs. And the FDA did nothing. RESP should be barred from producing any medical products FOREVER! Killing and injuring people for profit should not be rewarded. 

The FDA needs to grow a set and smite RESP from the landscape. RESP has shown time and time again that profit comes WAY before quality and safety. Whoever designed in the non bio-compatible foam and falsified the 60601 process should go to jail. 

[SleepyOzzy]

Well, only found out about this in Australia via news.com.au yesterday as some law firm in Melbourne is drumming up a class action. Been using the Dreamstation daily since June 2017 and just dumped out my logs to OSCAR this morning to see how many hours of exposure I've had, that's one plus is that everything is logged! I also reached out to BOC Sleep who I bought the unit off and have asked for a refund or replacement device under Australian Consumer Law - Now, deciding if after 4 years of exclusive use of CPAP if I just stop and see what happens..... 

[cathyf]

No doubt, Philips has already formulated those answers and decision matrices long ago.

I would have agreed with that 2 months ago. But having watched this train wreck unfold in real time, Philips is certainly doing a pretty good imitation of complete blithering idiotic cluelessness. "What? A plan? What's a plan? What do you mean we need a plan?"

[WakeUpTime]

In addition to everything else that's concerning about the Philips faulty devices, and the actual implementation of the Philips Recall, there's yet another possibility that one or two posters mentioned earlier: what if things become so bad that Philips decides to close out the entire consumer ventilator division, thereby having their total financial exposure capped.  No doubt discussions like that come up during executive meetings.  A series of events would need to occur before that happens, I would think:

• class action lawsuits expand significantly and get early support by preliminary judicial decisions (already 3+ countries)
  
• the rollout of the recall gets even more delayed due to "supply chain challenges" (chip shortages, etc.)
  
• the expanding 3rd (or is it 4th wave) of the CV; there's a lot of new labor required to make/service 3-4M devices
  
• the FDA takes much longer than mid-August to approve the 200+ "new foam" applications
  
• the company's reputation continues to diminish (they have at least 2 separate ventilator recalls now)
  
• other issues unfold that jeopardize the entire company's reputation and future profits
  

If that would happen, instead of getting fixed/replaced products in a few months, it could really turn into a 16-24 month recall, internationally anyway.  (No one, so far, has put any pressure on Philips to complete the recall by a specific date.)  It's probably unlikely to happen though - but we've said that about a lot of things over the past 18 months.  As bad as Philips seems to be handling this, from an end-user perspective, I'd rather they change their tactics and put their full support (actions, not words) towards providing end-user satisfaction.

[FLcracker]

Just when I think things are going so well....

And then I find that that the machine I CHOSE for my beloved Mizz Cracker, solidly dialed in for her, (with lots of help and guidance from this forum)....pulling consistent AHI's of 1- 2 and 3's and more than a few zeros thrown in for the past 2+ years... And then recently finding that it could be capable of possible serious health threats to her in the near future...

I only learned this recently because of an ad on the tube that was shilling for a law firm to sign up for a class action law suit against PR … WHUTTTT???!!

We pulled the plug on her PR auto...But that put her back in risk right away because of the severe SA that she endures... I contacted the folks I bought it from, and have a ResMed coming just a soon as they get them back in stock...but because of back orders, it will be a few (maybe several) weeks down the road before we receive one.

So yesterday, we opened and removed the foam from the PR's air chamber...No apparent sign of decomp, and the chamber was real clean. Put it back together, and used it last night...her AHI this morning read 0.4, so it will suffice, we hope) until we get the replacement ResMed...and I start the learning curve all over again....

We will be signing up for the CA legal option, in hope of at least recovering some or hopefully all of the cost of replacing the machine (just a few months past the 2yr warranty). We'll see... Usually only the lawyers are the big winners of any CA...

So, once again I'll be back and lurking with all of you hoseheads for awhile...asking questions and getting answers and info from some of the finest folks I've ever met online. Quoting ol' Red Green: “We're all in this together.”

Best to All, FLc

[btreger]

Over the past several days of reading the posts, and all the effort of trying to determine what Philips and the FDA might attempt to do. It hit me that all of that effort was meant for this thread and CPAP users.

It never really covered the full extent of the recall. There were 18 separate devices recalled for the same reason at the same time. Of those 18, only 4 were DreamStation products. The majority were high-end ventilators used by medical facilities.

One: These medical facilities/nursing homes, etc., are also worried about their own legal exposure.

Two: I find it hard to believe the FDA would approve the recall for just CPAPs, without first seeing the plans for all the recalled products.

Note: Just my opinion   

[SingingSam]

It is not knowable what the FDA will or won't do regarding the remedial actions that Philips has proposed.

That said, prior behavior is the best predictor of future behavior. The FDA has a long history of uncritical acceptance of data from established organizations like Philips. Moreover, the FDA's uncritical watchdog behavior corresponds with that of other 3 letter federal regulators.

The FDA is a major stakeholder in the recall, perhaps the biggest and most influential non-Philips stakeholder. The recall is — or should be — an embarrassment to the FDA. It is in the FDA's best interest for the recall to be handled swiftly with minimal media attention.

It will be uncharacteristic for the FDA to suddenly take their regulatory role seriously. To do so would delay the recall and elevate public awareness of the recall, which is not in the best interest of the FDA.

The FDA most likely will continue to act as it always has, in its own self interest. I expect to see the news soon that the FDA has approved Philips' recommendations with few if any exceptions.