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

[btreger]

FDA

Updated as of 02/09/2023


UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

Note: Most of the points in this article have been previously published...

One of my takeaways from this report is this:

Silicone-Based Foam

The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replacement program.

Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replacement program discontinue the use of their product. The FDA has reached this determination based on an overall benefit-risk assessment. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available.

UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication | FDA

[ST Dog]

Going to take apart my old unit clean it up swap the foam less tray they sell online.

So no only illegally sell a prescription only device, but also sell a device under recall. 

This is why they wanted the old System One machines  returned, so they would not be sold to unsuspecting patients.


I'd sure prefer a remediated/rebuilt DS than the crappy DS2 to replace my PRS1.

[WakeUpTime]

It'll be interesting to watch the DS2 sales marketplace post-Recall.  Already, I noticed an increasing supply of new unused DS2s appearing on the consumer sales sites.  There are many that shelved their new DS2s as backup, but some may reconcile any value of the DS2 as money towards another brand or other CPAP supplies like masks, etc.  

Once DS2s start to be recommended, retailed, marketed and promoted by Philips Resellers, unless there are growing additional new silicone foam fears, their cash value will likely grow.  That time might also see a significant bump in new DS2 consumer resale values as there are many folks, like myself, who don't have any insurance assistance that always look for ways to save annual treatment costs.  After a sleep study, or when replacing or upgrading equipment, patients are more likely to look at non-traditional resale markets, especially when they have some knowledge and experience.

Given the numerous negative comments on the DS2, especially from experienced DS1 users, and given there may be tens of thousands of new unused DS2s that may soon become available in the secondary resale markets, Philips is likely already working on a newer DS3 design.  They may even give it a new family name to distance itself from the years of DS negativity.  My guess is the successor to the DS2 will be announced in 2024.

Alternatively, Philips executives and the Philips Board may see future sales projections from the coming DS2-relaunch as being difficult.  Worldwide, Philips Class Action Lawsuits will continue to be in the news for at least another year, further tainting the brand value.  Philips may decide to not put any new money into consumer xPAP development and just pull in any profit they can from the existing development costs for several years to come, and just become anemic about the entire consumer xPAP market.

One thing Philips does better than most companies is securing, through significant financial incentives, relationships with resellers, distributors and recommenders (doctors, hospitals, medical reviewers, sleep labs, etc.).  It'll be interesting to see how former Philips authorized resellers (and recommenders) promote the Philips xPAP line post-Recall - especially since they've all been promoting other brands for survival over the past two years.

[ST Dog]

Given the numerous negative comments on the DS2, especially from experienced DS1 users, and given there may be tens of thousands of new unused DS2s that may soon become available in the secondary resale markets,

I've seen comments that currently resellers won't buy DS2s. Even new in the box.

Is it because they have too many already?

Philips is likely already working on a newer DS3 design.  They may even give it a new family name to distance itself from the years of DS negativity.

Hard to get away from the Dreamstation name soon since they have nothing else for BiPAP and the more advanced machines. I doubt they have even started advanced DS2 certification yet. (I haven't heard of ResMed Air Curve 11 variants either, so still making AC10 models).

So even with a replacement for DS2, there's a big gap only Dreamstation fills for a while. Anyone know how long it took to replace PRS1 with DS or AC9 with AC10? Was it all advanced models at the same time (or close) or was there significant delay for each variant?[/quote]

[Sleeprider]

I agree with the market analysis by WakeUpTime and will add, the shortage created by the recall, which continues in the retail market has opened the door to less expensive, mainly Chinese competitors and made them "acceptable". Many DMEs are steering customers to these more profitable and available alternatives. Since 2018 we have seen a doubling or more in CPAP and bilevel machine prices. For those that don't remember, you could buy a Resmed Airsense 10 for about $400, and the Aircurve 10 Vauto for about $800 from many online sources before all this started. It remains to be seen how durable the chip shortage supply chain problems will be. It's clear the worldwide chip and components market is overly dependent on Chinese manufacturing which has become increasingly volatile.

[btreger]

FIERCE

Biotech


Philips CPAP recall spurs another 82 reports of patient deaths, pushing the total to 346
By Andrea ParkFeb 13, 2023 09:51am

According to an updated tally published by the FDA this month, as of the end of 2022, the agency has received more than 98,000 medical device reports (MDRs) in response to the recall. The count stretches back to April 2021, when Philips first publicized the issues with many of its CPAP and BiPAP machines and other devices that would ultimately spark the official recall in June 2021.

The most recent additions to the tally include more than 8,000 MDRs received between Nov. 1 and Dec. 31. Those complaints include 82 reported deaths; in total, 346 deaths have now been reported in response to the recall.

Philips CPAP recall spurs another 82 reports of patient deaths (fiercebiotech.com)

[Gideon]

An FYI reminder since Philips is supplying many DS1 and DS2 replacements as APAP since you made that choice and they will come with standard APAP settings.

APAPs, all brands, need tuning to optimize to your apnea. They do not do this on their own. So take your daily charts and post them, in your own thread (start a new one if you don't have one), and get some help here at AB.

Yes there is that odd individual that the default settings are perfect for but that is the exception.

[WakeUpTime]

I've seen comments that currently resellers won't buy DS2s. Even new in the box.
Is it because they have too many already?

You bring up another interesting point about replacement units flooding into dealer stock rooms, with some being unclaimed and unallocated.  Philips (more precisely, a Philip's 3rd party) has been shipping out many new and refurbished DS1s and DS2s to Recall registrants, sometimes direct to patients, and sometimes to their “matched” Philips authorized dealers.  

There’s a lot of room for errors in that process, especially since most shipments don’t ship out with patient delivery notifications (if I’m not mistaken).

- Patient details may have changed over 20 months.  (I moved.)
- A few may no longer want them, or for a variety of reasons, no longer need them.
- Philips Dealer may be inactive.  (My original dealer for one unit doesn’t exist now.  The other was bought out by another company and changed names.)
- Philips Dealer may not notify (or not be able to notify) owners of their new replacement device arrival.
- Etc.

As a result, many dealers will end up with a supply of “extra” new and refurbished, DS1s and DS2s, that arrived at no cost, some with inaccurate current patient details.  Some dealers may just wait to be contacted by their intended device replacement owners.  New units with zero hours are certainly going to be reallocated eventually.  Refurbished units may become trial, demo, or refurbished units for other patients.  Philips is unlikely doing any follow-up and dealers likely won’t be complaining.  For dealers, they’ll reconcile that they can always provide another replacement, if requested, months later.  After all, recipients won’t be checking serial numbers.  Most don’t know if they’re getting a new, or refurbished, DS1 or DS2.  

Philips will likely keep those new DS2 production lines running, perhaps at full capacity, post-Recall.  They’ll also likely offer incentives to dealers that will be difficult to refuse.  There will continue to be a stream of newly diagnosed patients requiring xPAP devices. There will be many that will have no knowledge of this vast Philips Recall.  

Dealers won’t ignore the greater profit potential presented to them by Philips.  If they can make an extra $200-$500 profit (from new incentives) on the Philips brand, depending on the variant, they’ll do it.  If I were a Philips xPAP brand competitor, I’d soon change gears to provide volume discounts and other incentives to secure long-term relationships with dealers that get them to “prefer” selling their brand – just as Philips has done so extremely well pre-Recall.  It’ll be interesting to see if Philips is able to return to a 50%+ market share for new (for money) sales.  They’ll certainly do everything to try.

We’ve all become experts on the Recall, but for future new patients, searching “Philips DreamStation” almost exclusively brings up pages of site hits filled with marketing and sales information, rather than Recall information.  Philips may surprise us all with its strong ability to generate good future sales to newly diagnosed patients.  Most new patients go with whatever brand is proposed to them from their sleep center, insurance company, etc., without question.  My original DME said they're all about equal, but they had a stock room filled with Philips demo and new units, so that's what I was advised to get.  Philips will focus on getting all those recommenders recommending again, through various, sometimes nefarious, means.

[btreger]

CISION

PR Newswire

Sleep Apnea Devices Market Size to Reach USD 12.88 Billion in 2030 

Growth Projections:

The sleep apnea devices market is expected to register a CAGR of 6.9% over the forecast period and revenue is projected to increase from USD 7.00 Billion in 2021 to USD 12.88 Billion in 2030. A certified diagnosis could be an expensive as well as time-consuming process for the millions of individuals who are concerned they might have sleep apnea. Home-based sleep apnea testing is thus, on the rise, gradually increasing its demand. Testing for sleep apnea at home is a quick, affordable approach to determining whether one has breathing problems. It costs between a third and a fifth less than a sleep study completed in a clinic and is commonly reimbursed by insurance. Furthermore, on 10 May 2022, Sunrise, a sleep technology company located in Belgium, developed a portable, simple-to-use at-home sleep test that yields clinically appropriate results in a matter of hours, making these devices more easily available.

Sleep Apnea Devices Market Size to Reach USD 12.88 Billion in 2030 | Emergen Research (prnewswire.com)

[Moriarty]

The Australian Class action has been discontinued by the Lead Plaintiff because of the poor prospects of success.
https://view.apac.ph.mc.philips.com

Australian laws around class actions are quite different to US Law and payouts not so big.