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

[chasmm]

This is mostly pertaining to posts I've seen in various CPAP groups on Facebook, but I've also felt it some in this thread...

The almost "glee" with which people are announcing the potential new foam issues for Philips and the pronouncements of doom for the company bother me. Not that I give a grey rat's rear for Philips, but as a consumer of their products (4 CPAP machines to date), I sure hope they weather this and stick around.

If you use or have used Philips, then you want them solvent and able to address your machine issues. Even if you've purchased another MFGs machine, it would be nice to have something done by Philips. If the use of their machine ends up causing health issues for you, then you've got even more reason to hope they remain solvent and able to be held accountable.

If you don't use Philips, you still should want to have another major player in the CPAP business. The fewer the companies providing a NEEDED good, the more expensive it becomes. Monopolies or near-monopolies never work out well for the consumer.

I just don't get it, I guess.

[WakeUpTime]

Re: << above >>

Philips Revenues 2020 = $19.54 Billion Euros ($22.2 Billion U.S.)

Philips Capital Expense Allocation for Recall = $0.5 Billion Euros ($0.57 Billion U.S.)

Philips Estimated Total Cost of Recall = 2.5% of One Year's Sales Revenues

Philips Total Cumulative Revenues (2007 to 2021) from ALL Defective Ventilators = $ ? Billion

Summary:

(1) Philips needs to immediately replace (or refund) all defective units, whether or not they are currently in-use.  Philips sold defective and harmful medical equipment.  Buyers should be refunded their purchase prices, regardless of when they purchased their device and whether or not their recalled device is currently in-use.  Philips recalled device users (and health facilities) had no choice but to purchase their required replacement medical ventilators from other manufacturers.  

(2) Philips needs to address all associated pain and suffering (past, present and future) associated with the harmful effects of its products.

(3) Philips may have deliberately delayed or withheld knowledge and evidence of the defective nature of their products.  A thorough investigation needs to take place in order to determine the degree to which Philips may have conducted inappropriate, unsafe, misleading, or other behaviors that were ultimately damaging to users.

(4) The impact on the capital reserves and future revenues/earnings of Philips is irrelevant to the financial, health and safety damages that were inflicted on recalled Philips medical device users from 2007 to 2021 (and likely earlier).

At this time, significant respect, care and medical attention needs to be placed on the current and previous owners of Philips recalled devices.  Philips stock owners may be in more of a position to reflect on the prospective future financial health of the Philips company.

[btreger]

The reason I created a new thread, is that the DS2 machines appear to be defective, or need further testing to verify their safety. This is a different issue from the original recall. Also this thread is approaching a size that makes it unwieldy to find what has been posted.  Time for a new thread that discusses the DS2 and any problem associated with the silicone foam, and legal issues that will likely arise from rushing the DS2 to market to resolve issues with the DS1.

Thank you for explaining the reasons that were used to justify the need for a second thread. I now understand your thought process and can now move on from here. 

One thing to keep in mind going forward is that until there is a resolution to the new foam, there is still the issue of the refurbishment of DS1 machines. Most new articles that come out until that happens will include material pertaining to both.

[btreger]

DutchNews.nl

Four Dutch users take Philips to court over sleep apnea device

The claimants, who are suffering from headaches, respiratory problems, and cancer, say the damage to their health may be related to the use of the Dreamstation 1, a device that prevents sleep apnea, a health problem that causes a person to temporarily stop breathing while sleeping.

Some 50,000 of the devices were sold in the Netherlands. Philips said people who experienced problems should stop using the device and contact their doctor but for some people that was not an option,


https://www.dutchnews.nl/news/2021/10/fo...ea-device/

[btreger]

FDA says Philips knew about toxic foam for years before the massive recall

The FDA redacted parts of the 28-page report, citing a public records law exemption to protect trade secrets and confidential commercial or financial information.

Philips Respironics acknowledged receiving “limited complaints related to foam degradation [in the years prior to 2021], which were evaluated and addressed on a case-by-case basis. Issues relating to VOCs started to surface more recently, with testing and interpretation subsequently taking place with certified third-party experts, leading to the actions in the first half of 2021.”

Madris Kinard, a former FDA public health analyst with expertise in post-market surveillance, said she had been following the adverse event reports for the Philips devices and reviewed Form 483.

“It seems they were quite slow to take action. … This recall was far overdue, in my opinion, even with the concern that there might be a shortage of CPAPs available on the market if a recall had been initiated,” she said. “There are actions a company can take, with the help of the FDA, to help mitigate concerns like this. It doesn’t appear that the company worked with the FDA in any kind of collaborative fashion, to make a good faith effort to inform consumers 2-3 years ago when they knew of the issues.”

https://www.medicaldesignandoutsourcing....58kQw3Ueaw

[CactusJack]

My wife received a Dreamstation 2 machine a few days ago to replace her recalled DS. Is the old machine to be returned to Philips? No info on that came with the new machine and I didn't find such info here either (although my search-fu may not be so great.)

Thanks

[StratCat48]

My wife received a Dreamstation 2 machine a few days ago to replace her recalled DS.  Is the old machine to be returned to Philips? No info on that came with the new machine and I didn't find such info here either (although my search-fu may not be so great.)

Thanks

In the box my DS2 came in was a prepaid shipping label (UPS), a strip of tape to seal up the box, and instructions for the return. If Philips is refurbishing the returned DS's, I wonder if they don't request a return if they feel the machine is too old or too many hours to be rebuilt(?) Mine was only a year and half old.

[cathyf]

My wife received a Dreamstation 2 machine a few days ago to replace her recalled DS.  Is the old machine to be returned to Philips? No info on that came with the new machine and I didn't find such info here either (although my search-fu may not be so great.)

Thanks

If I were you, I would retain the DS for evidence. If it turns out later that your wife has been injured by DS use, then examining the machine may be necessary to properly diagnose her injuries and properly treat her.

It's too early to know what the long-term effects of PR use will be.

[btreger]

Taken from Facebook's "CPAP Reviews"

Michael Axelrod

Just got this email from Philips

“We would like to share an important update to the recall notification* for your Philips CPAP, BiLevel PAP, or mechanical ventilator device.

Your safety is our top priority. And we want to make sure that you, and as many patients as possible, can continue safely with therapy. This is why we have updated the US recall notification to align with the FDA’s recommendations in connection with these recalls and provide broader guidance on use.

If you use a BiLevel PAP or CPAP sleep apnea device and have already consulted with your healthcare provider, no further action is required of you with regards to this update.

If you use a BiLevel PAP or CPAP sleep apnea device and have not consulted with your healthcare provider, we encourage you to reach out to discuss the appropriate next steps for your therapy. This guidance is updated from our previous recommendation to stop therapy before consulting with your healthcare provider.

If you use a life-sustaining mechanical ventilator device, please do not stop or change your ventilator use and talk to your healthcare provider. 

What to expect next

Clinical information has been made available to your care teams to help them make the best decision about your treatment plan. Since your physician knows your medical history, they are the most qualified person to determine the benefit or risk of staying on your therapy until you receive your replacement device.
 
We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating and that timing is critical. We are working hard to complete this recall and will stay in communication with both you and your care team to share the most up-to-date information. While we have already made progress in shipping replacement devices, and have increased our production capacity, we anticipate the repair and replacement program in the US will take approximately September 2022 to complete. “

“Thank you for your continued trust.”

The email also confirmed that my machine was registered on June 17.

[us024077]

Received same email a few minutes ago.