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

[hegel]

"Parker Waichman LLP Files Injury Lawsuit Against Philips NV And Related Entities On Behalf Of A West Virginia Woman Who Developed Lung Cancer After Using CPAP Machines"

Correlation is not causality. what else was she doing during that time? smoking? eating oatmeal? living near a coal burning factory? come on. In any case, what machine was she using? how long?
Filing a lawsuit proves nothing. Sure, there may be a direct causal correlation. That can't be assumed based on the filing of a lawsuit.

[btreger]

Australian Government
Department of Health
Therapeutic Goods Administration

What is the TGA's role in a recall action and what has TGA done for this issue?

A recall action should not commence in Australia until the proposed action and communication are agreed to by the TGA. We give this agreement when we are satisfied that the action effectively mitigates the risks posed by an issue with a therapeutic good.

As part of our assessment, we often seek expert medical or scientific advice. Shortly after this recall action was announced, we convened our Ventilator Expert Working Group, comprising state and territory health officials, external independent clinicians, biomedical engineers, and peak health professional bodies such as the Australasian Sleep Association. The Working Group provides feedback on the appropriateness of the actions and communications from both the TGA and Philips.

After a recall commences, we monitor its effectiveness to ensure all affected product is fixed or removed from the market where this is needed. In some instances, further investigations or enforcement actions may also occur.

https://www.tga.gov.au/alert/philips-rec...entilators

Note: This complete article and link were posted here several weeks ago. I just went back and read it more thoroughly today.

We can see hear all the proactive measures the TGA has taken to fulfill its responsibilities to its citizens.

We have not seen any of these measures undertaken by our own FDA, who seem to have relied totally on the input they have received from Philips. Maybe they have done more, but you would think considering the seriousness of this problem they would have wanted to notify everyone asap.

[buggy285]

my DreamStation was just over a year old

[ST Dog]

Look it up...

Do random speculation with no evidence.

I highly doubt they used a substance not FDA approved.

[buggy285]

I really wish that Philips would have repaired my DreamStation 1 instead of replacing it with a DreamStation 2.

[StratCat48]

I really wish that Philips would have repaired my DreamStation 1 instead of replacing it with a DreamStation 2.

I have a Dreamstation 1 which is just over a year and half old. It's physical design works well on my nightstand and the display can be read easily while laying in bed. The Dreamstation 2 won't work out as well for positioning/orientation on the nightstand for the way the hose connection is located and accessibility to the water tank. I was hoping to have my DS1 upgraded with a new air chamber as well, but from posts I've seen here it appears I may be stuck receiving a DS2.
Did it appear that returning the DS1 was optional and you could keep it if you wanted to or was there any documentation that stated a return was required?

[MikeE3]

Did it appear that returning the DS1 was optional and you could keep it if you wanted to or was there any documentation that stated a return was required?

I too would have preferred my DS1 be repaired instead of getting a DS2. I tried the DS2 for a couple nights and went back to the AS10 I bought out of pocket. 1st reason if did that ... I can't use OSCAR with the DS2. 2nd reason: The hose is not on a swivel like the DS1. 3rd reason: it's not convenient to refill the humidifier tank. 

As to returning the DS1. There inclosed 'cover sheet' didn't say anything about it being mandatory to return it. It said "The enclosed Dreamstation 2 machine is provided as a replacement for your existing Dreamstation machine, To ensure proper disposal of your current machine, please return the affected machine following the instructions below". 

The instruction were just how to use the prepaid Fedex label to return it.

[btreger]

REUTERS
September 29, 2021

MDL Watch:

The FDA approved Philips’ plan to repair existing units by replacing the foam with a more stable alternative. Due to the lack of ready replacement kits, though, the recall will last until September 2022. Meanwhile, Philips has not offered “loaners,” and Medicare and most insurers will not pay for a new unit – estimated at $500 to $1,000 retail – unless the prior one was at least five years old.

https://www.reuters.com/legal/litigation...021-09-29/

[ST Dog]

REUTERS
September 29, 2021

MDL Watch:
Meanwhile, Philips has not offered “loaners,” 

How can they offer loaners if they don't have devices available? Same for DMEs, how many replacement devices do they have to loan or replace with?

[Moriarty]

Out of curiosity.  What is the oldest machine that PR has accepted as a return?  ...and has anyone had multiple machines exchanged or repaired?
I saw somewhere that Philips are saying 5 years is their nominated lifetime for one of their machines....

I have registered 4 machines with their Recall Contractor (Sedwick)... a 560 that I take away in our caravan when we go touring, 561 that has a faulty calendar that resets to a prehistoric date each time it turns on but which I carry as spare when travelling, and 2 DS1's that are in alternate use depending on where I am.

I'm not keen on the DS2 if Oscar can't read the data - so if they send me one (or more ) of them I might look to do a trade-in deal on another brand machine with a local retailer.