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

[btreger]

Philips CPAP Recall Support Group

Here is another recall story:


I received my "replacement device" yesterday. Its instructions tell me "before resuming therapy on your new or replacement machine, visually inspect the following accessories for evidence of black foam particles".

If it is brand new as opposed to refurbished, how could there be any possibility of black foam particles? So the wording suggests people will be sent either a 'new' machine or a 'replacement' - which I equate to refurbished and could possibly have black foam particles.

I tried ringing Phillips this morning on 1800-830-517 and it just loops the same message about being aware of issues etc and directing me to their website for updates.

[HairyReasoner]

Philips CPAP Recall Support Group

Here is another recall story:


I received my "replacement device" yesterday. Its instructions tell me "before resuming therapy on your new or replacement machine, visually inspect the following accessories for evidence of black foam particles".

If it is brand new as opposed to refurbished, how could there be any possibility of black foam particles? So the wording suggests people will be sent either a 'new' machine or a 'replacement' - which I equate to refurbished and could possibly have black foam particles.

I tried ringing Phillips this morning on 1800-830-517 and it just loops the same message about being aware of issues etc and directing me to their website for updates.

As I recall from other people posting about this, the accessories suggested for inspection are your humidifier tank, tubing, mask, etc.  Those are all accessories they are likely presuming you used with the recalled device, and they're suggesting they should be checked for contamination from the old device.  It isn't an indicator they're concerned the replacement device may be putting out bits of foam.

[HairyReasoner]

Philips CPAP Recall Support Group

This story adds a whole new wrinkle to the replacement fiasco:

I live in Australia. I got a phone call from Philips this morning and apparently, they are going to replace the front end of my machine.

They said when it arrives they will walk me through how to attach the tank and the back end of my old machine to the new front they send me.
 
I thought they would replace the whole machine with the dream station 2 which is black in color. 

The front end they are sending me is NOT the dream station 2 it is the dream station 1 (the same color as the one I have) with a different foam inside.
 
I’m a bit worried. I asked them if the one they are sending me is a reconditioned one. They told me it is not. They are telling me it is new with different foam.

I'm not sure what you mean by front end and back end.  If you're talking about the humidifier as the back end and the machine itself as the front end, it makes sense.  The recall is only regarding the machine.  There is no known problem with the humidifier. In all the cases I've seen where people have received a DS1 as the replacement machine, they were only sent the machine, and the instructions tell them to detach the humidifier from the old machine and attach it to the new one.

By the way, I've seen some people who have received the DS2 say they wish they'd got the DS1. The DS2 has some issues--number one of which is the data is encrypted so you can't get at it with OSCAR.

[btreger]

I'm not sure what you mean by front end and back end.  If you're talking about the humidifier as the back end and the machine itself as the front end, it makes sense.  

This is not my post, it is someone else's. I reposted it so everyone on this thread can read the experiences of other people that we are all caught up in.

They show that Philips has no documented strategy for replacement. There have been many posts here and other Recall Posts and they repeatedly show this.

This was just one person's experience, so if you happen to have it happen to you, you will know you are not alone.

[ST Dog]

They show that Philips has no documented strategy for replacement. There have been many posts here and other Recall Posts and they repeatedly show this.

I think they have it documented, just not released documents. Releasing such opens up a new set of PR problems. 

So gsr they;ve replaced DS1s with DS2s for the machines they can (DS2 version approved) and new build DS1s for the ones they can't use a DS2 for. 

To date know one has a verified rebuild/refurbished machine. One with a manufacture date prior to the recall, or clear signs of prior use.

I expect to start seeing those in January, increase they've managed to get returns and get them rebuilt.

[homedoc]

I could not agree with you more, Sir,

I also find their mask designs to be deficient biomechanically. The notable exception being the Mirge Quattro full-face mask which is the only mask I will use, though it, too, could use some refinements.

[btreger]

Philips Supervisory Board

 
As a separate and independent body, the Supervisory Board supervises the policies of the executive management and the general course of affairs of Philips and advises the executive management.


https://www.philips.com/a-w/about/superv...rNBt5UvsVQ


If you have any interest in getting in touch with any of these people I am sure someone can figure that out and pass the info on. I personally consider them part of the problem and not the solution.

There are a number of members that are in a more desperate situation and have tried calling Philips and gotten no were. They might want to try to reach out to one of these Board members, and of course, that would be their right to do so.

[btreger]

RE: >above post<


Philips CPAP Recall Support Group

Barry Gilbert posted this:

I went on Linkedin and sent connection requests to as many of the Philips Leadership team and other potentially relevant employees that I could find.

I then sent them messages asking them to help me get a replacement and that I couldn't afford to risk cancer or wait a year. I doubt any will respond or help, but I figured it couldn't hurt to try.

[WakeUpTime]

There was the posted video earlier from the PAP specialist in Australia who analyzed one of Philips' response letters - specifically noting that Philips does recognize a category of recall registrants who have "shelved devices".  Philips is NOT intending to replace those it seems.  The only way that Philips could possibly consider a device as "shelved" is that updated device data is not being uploaded to the Philips cloud.  

Therefore, I'm not sure that the Philips recalled device owner community realizes how alarming that is - that they could be waiting another 8-12 months for a replacement only to then realize that Philips was never actually planning to replace their specific devices.  Registration and confirmation DOES NOT necessarily equal replacement.  Ultimately, Philips will likely give in to those owners, if Philips has caught up with other replacements, and sufficient time has passed, and those remaining owners complain enough.  Alternatively, by that time, perhaps a class-action will have concluded and the primary law firm will have their own registration and judgement response plan that will also provide those Philips-perceived "shelved" device owners with assistance.

[Phaleronic]

Update from the FDA:

https://www.fda.gov/medical-devices/safe...ovdelivery