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

[Brantsangster]

Understand your frustration and feel exactly the same way. Not willing to take on any extra risks for cancer, etc I elected to buy a new Resmed machine on my own dime with the faint hope that reason might prevail and eventually when new machines started being issued, Phillips would consider a cash reimbursement for the machine I bought last year comparable to their cost of replacing their defective machine as they are doing now.

Alas, no such luck! It's "take the replacement machine or nothing". Anyone know who might want a brand new Dreamstation 2? 

[WakeUpTime]

Philips

"For device remediation managed by Philips Respironics, it is essential to ensure that affected devices are registered by the patient and also matched to their durable medical equipment (DME) provider. This is because your DME has the information needed to transfer your existing therapy settings to your replacement unit so that the device you receive is ready to use.  Please log in to the Patient Portal to see if you have been matched to your DME. If you have not, please contact your DME directly and ask them to register the serial number, so we can match the affected device and continue the process.

I did not have a match, so I contacted my DME... Their response was they would contact Philips and get my unit tied to their company, and that I might be getting a new confirmation number.

Incredible.  This is the core problem for a large percentage of Recalled device users who haven't yet received fixes/replacements.  Philips needs to be audited on that process, and to be required to publish monthly stats on % of replacements/fixes for each recalled device model.  Those results would likely demonstrate how Philips is significantly behind addressing millions of users in specific categories.  The FDA (and other agencies) would then be able to tell Philips, "What are you doing to fix that problem and address those users?".
 
Philips has primarily focused on recent on recent purchasers (past 5 years) of specific DS1 models who have somewhat recent data in the Philips Cloud, while also having accurate and current ownership details with their original place of purchase – with the DME maintaining that original data. 
 
There are lots of flaws in that process.  The user may have changed addresses since their original purchase years ago.  The user may not be the original purchaser.  The DME, especially smaller ones, may no longer have that original purchase data from many years ago (> 5 years).
 
The basic principle is that fixing a faulty device should not depend on any of those factors.  If I have a faulty food or prescription item, or faulty vehicle, it should not matter if I’m the original owner, if my original dealer still exists, if my original dealer has my current details, if I kept my original dealer (or the manufacturer) updated on my usage, if I have the most recent model, if I’m an active daily user of that product, etc.  Quite simply, those faulty products urgently need fixes/replacements, regardless of the electronic data stored at Philips, the DME, etc.  

The user should only be required to provide their faulty product details, and to return their recalled device, if requested.  Regardless of how the device was acquired, it's a faulty carcinogenic device that Philips is obligated to repair/replace.  Philips should NOT be allowed to qualify the product usage, original owner or original place of purchase to determine its obligation to pull that faulty foam out of circulation.

Philips will ultimately be able to surprise the industry with announcing that they’ve fixed/replaced all that they were safely and accurately able to fix/replace, given the details maintained and provided by DMEs.  Instead of replacing 5-15 million devices, they’ll replace perhaps 2 million, saying the rest were shelved, obsolete, unknowns, non-working, unreachable, etc. etc.  Philips will claim to be incapable of “safely and accurately” replacing all other defective medical devices.
 
Amongst my two recalled devices, the original DME on one no longer exists.  The DME on the other was bought out and combined with another company several years ago.  I had called and they don’t have access to any of my original records.  I never uploaded my data to the Philips Cloud on either system, except for perhaps the very early days. 
 
Also, what about users who purchased used/refurbished units?  They’re not entitled to a repaired “safe” unit?  Instead of the pressure being put on Philips to simply replace a faulty unit, Philips is pushing back to put the pressure on the original owners and DMEs to prove they are current, active and legitimate original owners - and that those original sellers continue to maintain original and current user records.
 
There are significant flaws in the process which the FDA and other worldwide regulators are not addressing.  Although I continue to get Philips updates, I have no doubt that neither of my Recalled devices will be replaced by the end of 2022.

[btreger]

Response from the FDA


On 05/13 I posted an e-mail I just received from Philips. The basic part of the e-mail stated that even though I was registered and had a confirmation number, I was not matched with any DME. I contacted the DME where I purchased the device, and they said they would contact Philips to correct this situation. This of course was taking place nearly a year after I completed the registration process.

StratCat48 responded to my post with this information: "CPAPs are designated a class II  medical device and as such (in the US) are strictly mandated to be able to be tracked per Federal law".

I said I would contact the FDA with all this information.

This is the response I just received:

Thank you for sharing this with me. I'm sorry you are continuing to run into challenges with Philips. We are looking into a variety of actions Philips should have been or should be taking. You may have seen our recent steps to get Philips to offer refunds as well as replace or repair their devices.

We will continue to take appropriate actions we have the authority to pursue. I just wish it didn't have to be so difficult for everyone involved, particularly patients, such as yourself.

Dr. Jeff Shuren, FDA

Note: As of today I am still not matched with my DME.

[tmiker]

Yes, is the asking price?

[btreger]

Updated FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

"The FDA remains committed to ensuring patients and providers have timely information about the recalled devices. In addition to our recent notice to the firm, we are continuing to closely monitor the reports and the risk posed by the foam. Our recommendations to patients and providers remain unchanged at this time and we will continue to provide updates as we gather and analyze additional information, including any further actions related to this recall."

— Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

We will continue to update the public about the status of this recall and share more information when it becomes available.

FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls | FDA

[btreger]

MASS DEVICE

FDA says Philips ventilator recall produced over 21,000 device reports, 124 deaths

Within the MDRs (Medical Device Reports) received by FDA — both mandatory reports from Philips and voluntary reports from healthcare professionals, consumers, and patients — a range of injuries were reported, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.

FDA says Philips ventilator recall led to 124 deaths (massdevice.com)

[btreger]

MDL 3014 In Re: Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation


Interim Preservation Order (Doc. No. 578)

This is interesting because it deals with the Trilogy Machines. Philips is not manufacturing new machines, so they need to get their customers to return their recalled machines so they can be refurbished and returned.

Exhibit B
 
Packaging and Storage Protocol

Page 15

This section describes in detail what are the steps to accomplish this. 

Microsoft Word - Trilogy 5.19.22_ PROPOSED FINAL 326pm.docx (uscourts.gov)

[btreger]

Meant for DreamStation Go Owners;

This is where we are one year later. Philips does not even have the FDA approval completed for the remediation process for the DreamStation Go.

[Dog Slobber]

FDA says Philips ventilator recall led to 124 deaths (massdevice.com)

The article does not say that at all.

[btreger]

The article does not say that at all.

Are you saying the article did not say this:??

"According to the FDA’s notice, the agency received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown in Philips Respironics’ ventilator devices between April 2021 and April 30, 2022".