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+--- Thread: [News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS (/Thread-News-RECALL-THREAD-IMPORTANT-PHILIPS-DREAMSTATION-SYSTEM-ONE-USERS)
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What about PRS1 users? - archangle - 09-22-2021
Has anyone heard about Philips responses for PRS1 machine users? All I've heard about is DS1 users.
Has anyone with a PRS1 machine signed up with Philips and gotten any kind of info? Or a new DS2 machine?
RE: What about PRS1 users? - HairyReasoner - 09-22-2021
(09-22-2021, 09:43 PM)archangle Wrote: Has anyone heard about Philips responses for PRS1 machine users? All I've heard about is DS1 users.
Has anyone with a PRS1 machine signed up with Philips and gotten any kind of info? Or a new DS2 machine?
For what it's worth, my DME told me the System One machines will be replaced with Dreamstation 1 units. I'd assume they would be reworked machines, but my DME indicated they will be sending out "new" machines--however they define new as being under 400 hours. I was also unclear if she meant the new ones would be sent to replace DS1 machines, or that they would replace all--including the System One units.
Of course, you talk to 10 different DMEs you probably get 15 different answers.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 09-23-2021
FDA Updates FAQs on Philips Recall
Posted by Sree Roy | Sep 21, 2021, | CPAP & PAP Devices, FDA
Q: Are the product codes for CPAP and BiPAP machines on the FDA’s device shortage list?
A: Yes, all the product codes under which CPAP and BiPAP machines are classified are on the device shortage list due to device availability issues. These include product codes BZD, NOU, CBK, MNT, and MNS. The majority of these devices are classified under product code BZD.
In determining whether a medical device is in shortage, the FDA considers the entirety of relevant and reliable information and data available to the FDA at the time of a decision.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - mrmagloo - 09-23-2021
For a bit of clarity, the Dreamstation 2's 510K was approved on July 10, 2020 - over a year ago, predicating the Remstar Auto A-Flex HT and the Remstar SE. So, to Arch and Hairy's point, this Sept 1 approval has nothing to do with the DS2 approval status, other than it was approved as a remedial solution for the DS1 recall. That is one approved solution. The retrofitting is separate, and I don't believe we've seen an approval there yet. That is where the DS2 foam itself will be looked at a little closer. But, I think there is a very high expectation that it will be approved or they wouldn't have approved the DS2 for replacement in the first place.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - shlevinemd - 09-23-2021
I believe I have significant complications from the dream station.I am trying to locate physicians with experience in managing this particular problem
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 09-23-2021
(09-23-2021, 11:35 AM)shlevinemd Wrote: I believe I have significant complications from the dream station.I am trying to locate physicians with experience in managing this particular problem
I am so sorry to hear that. Good luck, and if you can please keep us updated.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 09-23-2021
Unanswered questions:
In an effort to help resolve relevant questions we have so far hit the preverbal brick wall. I decided to reach outside the US to see if more information might potentially be available.
Today I sent e-mails to:
Australian Government
Department of Health
Therapeutic Goods Administration
And the;
Canadian Thoracic Society
I have received notification of the receipt of my e-mails. For now, all I can do is sit back and see if they can provide any new useful information.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Zalagar - 09-23-2021
Fun stuff. After over a month of waiting for the sleep lab to send my sleep study results to my doctor, they finally did and my doctor's assistant sent my prescription to a DME, a Few days later the DME called me and confirmed they got the prescription. I told them I would like to receive a ResMed Airsense 10, they told me ResMed canceled their order due to them having so many backorders or w/e. They said the only machine I could get is a Dreamstation 2, but those are back-ordered without an ETA for when they could even get one. So essentially I went through all the hoops for nothing. With the best result being I could get a Crappy DS 2 within the next year.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - shlevinemd - 09-24-2021
Thanks very much! I will keep you updated
Thanks very much! I will keep you updated
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - ger365 - 09-24-2021
(09-23-2021, 10:46 PM)Zalagar Wrote: Fun stuff. After over a month of waiting for the sleep lab to send my sleep study results to my doctor, they finally did and my doctor's assistant sent my prescription to a DME, a Few days later the DME called me and confirmed they got the prescription. I told them I would like to receive a ResMed Airsense 10, they told me ResMed canceled their order due to them having so many backorders or w/e. They said the only machine I could get is a Dreamstation 2, but those are back-ordered without an ETA for when they could even get one. So essentially I went through all the hoops for nothing. With the best result being I could get a Crappy DS 2 within the next year.
Going to be a bad problem, call around and see it you can find one elsewhere and have script sent to them. Have you checked the list above sellers?