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

[Moriarty]

One of the local CPAP suppliers here said that so far their customers have been getting DS-1's as replacement machines because the DS-2 has not yet been approved in Australia.

She said that when I was talking to her about buying a Resmed unit as a replacement for my DS-1.
I suppose she knows what she is talking about.

[btreger]

SoClean CPAP Lawsuit: Philips Knew for Years that Its Products ‘Created Serious Risk of Harm’

By Michelle Llamas
Edited By Sophia Clifton
Published: December 16, 2021

SoClean filed an amended complaint in its CPAP lawsuit against Philips, stating that the CPAP maker has been blaming SoClean’s ozone devices for its CPAP recall when it has known for years that its products could cause serious harm to consumers.

https://www.drugwatch.com/news/2021/12/1...risk-harm/

[WakeUpTime]

<< above >>

There's another option that you might have, given that you're in Australia.  Since there 'may' be issues with the new replacement foam (see earlier posts in this thread), and since the DS1's foam positioning is significantly more focused (more stress on the foam than on other systems), and since you happen to live in Australia and might be able to take advantage of the consumer protection laws to possibly get a completely refund on the cost of your initial DS1 purchase, then I'd try to get a refund and use that towards the purchase of a new ResMed equivalent system (either AirSense 10 or 11).  

On the other hand, perhaps you don't qualify for a refund because of the age of your DS1 (or other reasons).  Also, many people strongly prefer the DS1 and dislike many features about the DS2s (encryption, hose position, etc.).  

It's just a thought.  You're fortunate that you're living in a country that provides you more options for the Recall.

[WakeUpTime]

<< above >>

Who would have thought that SoClean would become an ally for all Philips recalled device owners?  Philips may have made another strategic error legally in blaming SoClean for everything.  Naturally, SoClean will do everything to protect itself and is in a great position to uncover many of Philips' faults.  

Personally, I agree with some of SoClean's claims.  Philips seems to have known about the foam issues for a long time.  Although SoClean's internal cleaning likely quickened the faulty carcinogenic foam breakdown, the root problem was Philips' faulty carcinogenic foam.  Philips relied on users retiring their systems early and frequently through continual upgrades, but the DS1's foam positioning, along with the dramatically increased breakdown brought on by SoClean, really was a volcano waiting to erupt.  It would seem they decided to come clean now, and appear to be the good guys, or face even more serious accusations, possibly criminal, down the road.

[btreger]

Philips Recalled CPAP, BI-LEVEL PAP, and Mechanical Ventilator Products Litigation, MDL. No. 3014

Some interesting info on this case:

Pretrial Order #1

ORDER re Emergency Motion to Stay [8] and Response to Motion [11]:

The court appreciates the need for Philips RS North America LLC (Respironics) to comply with its obligations with respect to the FDA Recall Remediation.

The court, however, lacks information about why Respironics is unable to preserve the items identified in the brief in response to its emergency motion, i.e., the PE-PUR foam, memory cards in the devices, and other component parts of the machines that are removed in the retrofitting process. [9].

At or before 1:00 p.m. on 11/17/2021, Respironics shall file a reply brief, not to exceed ten pages, to address why it is unable to preserve those items.

[btreger]

RE>above<

Some additional info:


(D)with respect to all the DreamStation 1 Devices sent to Respironics as part of the 
FDA Recall Remediation that will be replaced rather than repaired, Respironics 
must preserve, store, and catalog those DreamStation 1 Devices so that the 
DreamStation 1 Device can, if possible, be traced back to the specific individual 
who used that device; and

(E) with respect to all the DreamStation 1 Devices sent to Respironics as part of the 
FDA Recall Remediation that will be remediated and returned to the sender,
Respironics must preserve, store, and catalog with the original serial number the 
blower box, PE-PUR foam, and SD card removed from any retrofitted
DreamStation 1 Device so that the blower box, PE-PUR foam, and SD card
can be traced back to the specific individual who used that device.

IT IS FURTHER ORDERED that if interim lead counsel want to retain an expert 
for the purpose of advising them with respect to preservation issues, Respironics must 
provide expert access on a reasonable basis to the DreamStation 1 Devices returned to 
Respironics pursuant to the FDA Recall Remediation that is in Respironics’ possession as 
well as any materials removed from the DreamStation 1 Devices as part of the FDA Recall 
Remediation;

MDL 3014 | Western District of Pennsylvania | United States District Court (uscourts.gov)

[edspyhill09]

The U.S. FDA is there to protect corporations.  The FDA will never put a corporation on any schedule that helps users, patients.

[ST Dog]

The court, however, lacks information about why Respironics is unable to preserve the items identified in the brief in response to its emergency motion, i.e., the PE-PUR foam, memory cards in the devices, and other component parts of the machines that are removed in the retrofitting process. [9].

There's shouldn't be a SD cards in any returned device. I sure as he'll wouldn't send mine with the machine.

[ST Dog]

The U.S. FDA is there to protect corporations.  The FDA will never put a corporation on any schedule that helps users, patients.

Your wrong. If that was the case all the suits over Vioxx, Oxycontin, etc. would have been dismissed.

And it wouldn't take years to get new products approved.

[WakeUpTime]

(D) ... Respironics must preserve, store, and catalog those DreamStation 1 Devices so that the DreamStation 1 Device can, if possible, be traced back to the specific individual who used that device; and

(E) ... Respironics must preserve, store, and catalog with the original serial number the blower box, PE-PUR foam, and SD card removed from any retrofitted DreamStation 1 Device so that the blower box, PE-PUR foam, and SD card can be traced back to the specific individual who used that device.

That news got me teary eyed.  Perhaps some of my 'educational' e-mails that I sent to a number of those top law firms got them to more strongly push for some things that they never would have otherwise.  On one specific occasion, I blanketed some of those firms with an e-mail stating specifically to NOT let Philips destroy the returned foam, along with many corresponding reasons, including the link to current/future health conditions of individual users.  (Though good lawyers would likely know anyway how vitally important it would be to preserve all evidence.)  

It will be incredible if a connection could be made between foam conditions and individual users.  That will be a day, indeed.