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

[btreger]

Latest update:

On 10/19/2021, Philips is focusing on replacing the affected DreamStation with the new DreamStation 2, which Philips has in stock. Many of our patients received the replacements already. We believe the units used with ozone had a higher priority in the process. The repair has not started.

On 9/27/2021, Philips confirmed they are still waiting for FDA clearance, probably a 510(k) approval, on the new design. The approval at the beginning of this month was for the new foam design, but in order to service the impacted units, it seems FDA needs a holistic review and approval process (we don't have details). No old units are being re-managed or re-manufactured now (due to legal reasons, the process cannot be called "repaired"). Some patients are getting new DreamStation 2 replacement machines but they are only a small portion of the entire community. How lucky they are!

Note: This came off a large DME's website, so I cannot post the link.

[LindanHotAir]

I know the Bipap AutoSV has a different blower (much larger and capable of 30 cm pressure) from the DS Auto CPAP.  The exteriors look the same except the AutoSV front panel is black.

Has anyone who received a replacement DS1 of any version gone into the clinical menu info screen and displayed the machine hours?

[clintber]

I wish I had checked that before using. I don't know where it was when I received it. My "new" BiPAP shows 28 machine hours and the same blower hours. I doubt I used it that much in two days!

[Sleeprider]

I wish I had checked that before using. I don't know where it was when I received it. My "new" BiPAP shows 28 machine hours and the same blower hours. I doubt I used it that much in two days!

I think you got a new machine, however since you can't look at the Oscar data to see the usage and settings, I guess we'll never know.

[clintber]

And you’re a “moderator”?

[Sleeprider]

Clintber, if you have the Dreamstation 1 you can read the data. The Dreamstation 2 encrypts data. Dreamstation 1 unis have been recalled due to a foam that can break down and pose health hazards. If you are using a DS1, then look at the detailed data. All hours should be accounted for. If you see sessions that are not your own, then the machine was tested or used as a demo, assuming that use was not deleted. Since machine and user hours are equal, you should see everything.

[clintber]

I see no sessions that were not mine. Would these sessions appear even though there was no SD card in the machine when I got it?  All I got was the machine, no sd, no power, no humidifier, no fine filter.  While there are no sessions from days when I wasn’t in possesion of the machine there is about a 0.2 hr difference between the machine hours and the total time shown for all the seesions in Oscar over the past two days.

So I guess it had 0.2 hours machine time when I got it.

[chasmm]

Someone reported receiving a replacement Trilogy BiPAP. I had not heard of this device before, but evidently, it's quite expensive as it is a ventilator. They believe that their replacement is refurbished, but are not certain.

[btreger]

From the Facebook Cpap Reviews Forum

This has also has been posted on this thread before, and the recommendations were to keep your recalled machine.


Pros:
 Do not return your recalled DS1, it could be evidence in future litigation 


Con's:
 Keeping it reduces the supply for others. It will have no bearing on any sort of court case as the problems with the machines are well known. Your registration for the recall proves you had the machine.

I do not pretend to know the answer to this. I think everyone will have to make their own decision.

[chasmm]

Since my post yesterday, I've seen 3 new posts on the FB Recall/Other groups about receiving a replacement BiPAP machine from Philips. 2 of them stated they were DS1s, the other did not.