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

[WakeUpTime]

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Interesting survey results from DMEs.  

"Clinicians most commonly reported first learning about the recall from Philips (25.0%)."
- Only 1/4 learned about the Recall from Philips directly?  That's so bad that 3/4 of DMEs first learned about the Recall from the news media or their patient customers.

"Most clinicians (62.4%) reported that they recommended patients continue using a recalled device.  Only 9.3% of clinicians reported encouraging patients to stop using their recalled device. Clinicians reported that 59.9% of patients continued treatment with their recalled device, whereas 26.5% stopped treatment. "
- Interesting position to be in.  I suspect, for legal reasons, they stuck to Philips' formal announcements.  When Philips said "stop using", that was their advice.  In the weeks that followed, as the strength of Philips' warnings and cautions become lighter and lighter, so did the DMEs' advice.
- In reality, the decision whether to continue using their Recalled device was determined by many other factors, not solely the advice of the DME that was utilized for the initial purchase of the Recalled Philips device, such as insurance factors and degree of self-treatment.
- Less than 10% of DMEs advised patients to stop using their Recalled Philips device?  I suspect that 65-75% of self-treating (self-managing) xPAP users changed to another xPAP brand in the months that followed the Recall announcement.
- 1/4 of patients stopped treatment?  That's very bad, if it's indeed an accurate number.  The statistic doesn't specify if the stop was temporary (until receiving a free replacement).  Unknown to the DME, the patient may have obtained another brand of xPAP without going through their Philips DME.  Some may have changed to another form of treatment.  

"Clinicians reported that over one-third of their patients were still waiting for a replacement machine."
- That's not good, considering the survey was done between 12 and 18 months after the Recall was announced.

"Most (83.3%) clinicians reported the recall affected their patients' trust in medicine."
- Much has indeed changed, such as trust in medical supply manufacturers (especially Philips), DME advice and recommendations, government medical agencies, consumer protection agencies, etc.

I've now learned that advice from a DME is similar to advice from BestBuy.  (That's not to say that it's bad, but it's heavily biased towards income and inventory.)  Even worse, it would be like getting advice directly from a specific manufacturer, as we've learned of the outlandish incentives and forced tie-ins that Philips had with its network of authorized DMEs.  DME advice is almost definitely not completely independent and unbiased, though there are exceptions.  

Although most Philips dealers became much more aware and involved with other xPAP manufacturers post-Recall, many now will switch back to mostly promoting Philips, because the Philips sales and profit incentives will be significantly better.  There are many DMEs that have closets filled with unallocated (free) replacement DreamStation 1s and 2s.  (Not all owners received replacements direct from Philips.) Philips will provide tremendous marketing incentives to DMEs (free demo units, free masks and supplies, etc.).  Philips' primary strength is its global marketing and strong direct tie-in with the medical community.  As the experts here stated early on:  Patients are not Philips' customers.  DMEs are Philips' customers.

[Labromaniac]

Well after innumerable years, I finally received a box from Phillips with a replacement for my system One ASV machine. I am confused by what I have received and perhaps you can help me understand. It is designated as "REP DreamStation BiPAP autoSV, DS". It lists a serial number. They are asking me to send back my very old System One ASV machine.

Does the "REP" designate that this machine they sent me is refurbished or repaired from recalled stock or other user's and NOT a new machine?

I don't see this model listed on any of the commercial websites. Is it an old model or outdated? It also looks like maybe Phillips has no current ASV machine new on the market.

I am not sure I trust this machine and wonder if it is saleable or donate-able?

I have moved on years ago now to ResMed.

They also told me that if I do not send back the old machine, they may charge me for the "new" machine.

Thanks for your help on this confusing topic.

[WakeUpTime]

They also told me that if I do not send back the old machine, they may charge me for the "new" machine.

From all my readings, I've never read even one instance of Philips vigorously following up on that "threat", beyond initial replacement shipment documentation.    So, you're "safe" doing whatever you wish with your previous Recalled very old System One ASV device.  

I'm not sure what value or re-purpose your old System One ASV has, beyond being a backup (or backup to your refurbished DS1 ASV).  I'd only use it as a backup (or emergency use device) if it were properly defoamed, which is very easy to do on the System One system units.  I don't think Philips would have any use for a System One ASV now and it's very likely they'd only dispose of it.

I am not sure I trust this machine and wonder if it is saleable or donate-able?

I just checked Craiglists for several difference cities.  Replacement refurbished Philips xPAPs seem to be showing up everywhere now.  I think many switched to another brand over the past 2.5 years while waiting for their replacement device.  They've tweaked their new brand to their liking and gotten used to new sleep algorithms perhaps, so even keeping a Philips as a backup to some people is only taking up space and gathering dust.  The value of a DS1 replacement unit is quickly declining because of newer models, declining warranties and device age.  There are new replacement Philips DS1 AutoCPAPs selling on CL for as low as $150-$200 now depending on the marketplace, and some are giving them away or donating them on other sites.

[Labromaniac]

Thanks for all of that. I have since found out it definitely is a refurbished old unit. I have entertained donating, selling, throwing it away etc. I have come to my own personal decision that I no longer trust Phillips for anything and don't want the machine. My ResMed ASV works GREAT. One thought I had is that the big box comes with a prepaid return shipping label to return my old recalled System One ASV. I think to rid myself of the "problem", I might just apply the sticker to the box and the refurbished unit and send it right back to them, thus refusing acceptance and being done with this silly adventure. I appreciate your answers as always!

[Tampa Jim]

The court order required Philips to give us options on our affected machines. Return them, return them to Philips and require them to keep them as evidence or keep them ourselves as evidence. They do not have to be returned. If you carefully read the micro legal speak on the Philips portal, enclosed RMA details, etc. it's in the information, neatly hidden. Here's the link to the "Preservation Registry" if you want to exactly follow the court order in keeping your old device. Best wishes.

https://forms.office.com/Pages/ResponseP...42NVNDQy4u

On a side note, they're all over the place. My DS1 was replaced with a brand new DS2, after nearly 1.5 years. My wife's DS1 was replaced with a used DS1, after an additional couple of months. My DS Go is still awaiting replacement to this day. Apparently, being a "priority replacement" doesn't carry much weight.

[btreger]

FDA

Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication

Date Issued: November 21, 2023

The U.S. Food and Drug Administration (FDA) is providing additional information about a product recall related to the use of SoClean2 and SoClean3 equipment used to clean, sanitize, or disinfect CPAP devices and accessories. 

On November 16, 2023, SoClean announced a voluntary recall to notify users of:

A new version of the User Manual for SoClean2 and SoClean3, which includes: additional set-up, use, and cleaning instructions; and additional instructions for users regarding how to detect and deal with unexpected ozone exposure and

The availability and use of a hose and mask adapter, which is intended to facilitate the use of the SoClean2 and SoClean3 equipment without ozone entering the CPAP.

Philips is really going to love reading this:

Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication | FDA

[btreger]

FDA

Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication

Date Issued: November 28, 2023

The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers to carefully monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating.

The FDA recently received medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while people are using Philips DreamStation 2 CPAP machines. The agency observed a recent increase in reports about these thermal issues with DreamStation 2 CPAP machines. Between August 1, 2023, and November 15, 2023, the FDA received more than 270 reports of problems associated with the device, compared with fewer than 30 MDRs received in the previous three years.

Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication | FDA

[btreger]

Regarding the above post: Philips DreamStation 2


Please view this YouTube video by Nicko Dundai 

[tbhausen]

Out of the frying pan and into the... fire? I'm truly sorry for all of us caught up in this mess.

[BoxcarPete]

FDA

Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication

Date Issued: November 28, 2023

[snip]

The agency observed a recent increase in reports about these thermal issues with DreamStation 2 CPAP machines. Between August 1, 2023, and November 15, 2023, the FDA received more than 270 reports of problems associated with the device, compared with fewer than 30 MDRs received in the previous three years.

Looks like somebody found a source for lower-cost turbine bearings. Enjoy your promotion while it lasts, buddy!