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

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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - WakeUpTime - 08-26-2021

It's unfortunate that Philips hasn't provided any detailed logistics of their coming procedures.  For those who will be getting DS2 replacement systems, I suppose that the technician will require the previous device in order to setup the new DS2 with the returning device's settings.  They'll have to be extremely careful with that process - unless of course that Philips will be forcing those users to go through a DME for the setup procedure.  Lots of questions and concerns.  No answers yet.  In some ways, the foam replacement procedures will be "easier" as it doesn't require getting into a user's settings - except to run a self-test perhaps.


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - buggy285 - 08-26-2021

Im hoping that this all gets resolved quickly. in the meantime im going to inspect my machine daily for any signs of the black specks of foam ive been hearing about. im in a difficult spot, cant go with out my CPAP but can't afford to replace it.


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Zalagar - 08-26-2021

(08-26-2021, 06:13 PM)DaveCar Wrote: I can't see how they could expect a user to box up a unit, ship it, wait for it to be repaired etc.

Re: Blowing out the blower during repair.. I dunno, I have some black film near the blower exit hole that I figure is also coating the inside of the blower case.  I dont think that's going to just blow out.  They better be replacing blowers too.

From what I've heard from the few people that have received instructions from Philips on returning their devices for replacements(Almost 100% certain for DS 2's, since the new DS 1 chambers are still waiting for approval.), I'd have to go back and re-read their statements again, but I'm pretty sure they said they received a return shipping label and return instructions for returning their machine. They didn't elaborate if it came with a box to return the machine in or not, but they for sure didn't have a new machine cross-shipped.


As for the blowers, we can all hope they will replace them, but more likely than not, they will probably use like Isopropyl Alcohol or something similar to clean them out, since it will clean it and completely dry with no residue or chance of hurting them.


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 08-27-2021

NBCDFW 5 RESPONDS

Consumers Search for Answers After Breathing Machine Recall

The FDA said it’s monitoring the recall, including the corrective actions taken by Philips. The FDA said the company can not distribute repair kits or replacement devices until it can show the FDA the mitigation plans. Philips has to test their repair kits and the FDA said it will review the data before the company can ship the kits to consumers.

Note: The rest of this article is a repeat of other articles. I posted this paragraph because it seemed relevant to the current conversations.


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - SingingSam - 08-27-2021

"Philips has to test their repair kits and the FDA said it will review the data before the company can ship the kits to consumers."

Whoa! Did the report really say, "ship the kits to consumers"? I wasn't expecting that.


RE: SERVICE REPAIR PROCESS - MikeE3 - 08-27-2021

(08-26-2021, 12:28 PM)WakeUpTime Wrote: .... perhaps 2-3 weeks (including all shipping times)?  

Good luck with that time frame. Last winter before all this started my DME returned my DS1 to Phillips for repair. I dropped it off at the DME and pick it up from them too. It took over 6+ weeks for Phillips to get it returned to the DME. The DME told me 6-8 weeks is a typical turn-around for repair work.


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 08-27-2021

(08-27-2021, 09:15 AM)SingingSam Wrote: "Philips has to test their repair kits and the FDA said it will review the data before the company can ship the kits to consumers."

Whoa! Did the report really say, "ship the kits to consumers"? I wasn't expecting that.

Consumers Search for Answers After Breathing Machine Recall – NBC 5 Dallas-Fort Worth (nbcdfw.com)


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - SleepyCPAP - 08-27-2021

“ Whoa! Did the report really say, "ship the kits to consumers"? I wasn't expecting that.”

NBC does not know that if Philips Respironics says “customers” it does not mean “patient” or “end user”. It means DME. My guess is the reporter changed “customer” to the word “consumer” on their own.

But I would love to have Philips Respironics just ship me two pieces of foam! I’d even take a plain sheet of the stuff and cut it. PRS1 is so easy to disassemble and reassemble. If they want the old foam back, I could mail it. Cut out the DME or repair shops and it is done in minutes! I’ve already written to the online store where I bought my two machines over the years, suggesting I’d prefer to get the foam parts myself.


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 08-27-2021

RE: > Zalagar Post #1309 <

If you did not have a chance to read this, please do so.

I am going to quote some of it and add my own comments.


" The DS 2 blower chamber is pretty much identical to the DS 1's, even has foam in similar spots, just with the new white foam. They will most likely swap the chamber, blow out the turbine in the blower fan, and re-assemble it and shoot it back to us". 

 With a video link to support his findings.

 It took me a day for this post to sink in. Zalagar has presented a clear and easy-to-understand no brainier eloquent solution we have been waiting months for.

It also raises a lot of unanswered questions:

Prior to the recall, Phillips was talking with the FDA. They could have provided the FDA all the information they required.

The FDA if satisfied, could have given Philips permission to start the DS 1 recall immediately after they announced the recall.

They still would require Philips to provide detailed information on the other recalled products, but at least the DS 1 process would be started.

It should have worked like this:
Recall Notice
Sign-up, receive a confirmation number
Within 15 seconds, you would receive an e-mail, with your confirmation number, and detailed information on what steps to take next.

This would have been a win, win for everybody. Philips would look good. They provided an immediate solution. The FDA would look good, for allowing one recall to take place. We would all, this includes the rest of the world, would know for sure the, when and how are machines would be repaired.

So what happened?

I have one possible answer. Philips did not want to submit a certified clinical medical report on the new foam it was preparing to use in the repair and the new DS 2. It had something to hide.


RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - oldgreenhead - 08-28-2021

(08-27-2021, 02:15 PM)btreger Wrote: RE: > Zalagar Post #1309 <

So what happened?

I have one possible answer. Philips did not want to submit a certified clinical medical report on the new foam it was preparing to use in the repair and the new DS 2. It had something to hide.

btreger

You are onto something  Clearly Philips is NOT doing the right things.  Also a possibility is that Philips is not sure what they want/need to do to minimize the effect of the design error/recall.  Therefore, they are slow-playing the whole thing.