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

[btreger]

HME News

PHILIPS WIDENS SCOPE OF RECALL
THE COMPANY EXPECTS FURTHER TESTING RESULTS IN Q2

“It’s difficult to deny a patient with an older unit a repair if they are still using it and sometimes patients have two units that they use alternatingly and we felt it was difficult to say no on an arbitrary five-year limit, even though we know that in the U.S. patients are entitled to new reimbursement,” he said. “But the fact that there is new reimbursement does not mean that they should stop using the old product, right?” 

https://www.hmenews.com/article/philips-...-of-recall

[WakeUpTime]

HME News

"...even though we know that in the U.S. patients are entitled to new reimbursement,” he said. 

Is the Philips CEO stating that all U.S. "patients" (recalled device owners) are going to get new replacement devices provided by Philips?  
Or was he stating figuratively that device owners generally qualify to receive a new xPAP replacement system, through their insurance company, every 5 years?  I suspect he was speaking generally, for those owners who purchased their device with insurance assistance.

It seems that the Philips CEO had previously felt that a medical product safety recall should not be applicable to those whose devices are more than 5 years old.  They should just continue to inhale/digest the faulty decomposing Philips foam I suppose.  

Doesn't the Philips CEO realize there are also "patients" (Philips device users) who don't have an insurance company that will provide a new replacement (partially or full reimbursed) every five years?

It's amazing how new (somewhat vague) corporate policies are disclosed in these seemingly casual media interviews rather than through official press releases.  Perhaps this way, the Philips corporate office could later state that the full context implied a much more narrow group of owners.

AMSTERDAM, the Netherlands – Philips now expects to remediate about 5.2 million recalled devices, forcing the company to increase its provision for the program by another EUR 225 million and to slightly delay its conclusion. 
The company felt it had to be “more lenient” on accepting recall registrations coming in for older devices, says CEO Frans van Houten. 
...
To date, Philips says it has produced 1.5 million repair kits and replacement devices, with about 700,000 in the hands of customers. 

How many of those 1.5M repair kits + replacement devices were new DS2s?  What's the distribution, by country?  How many received serviced foam replacements (repair kits), by country?  

For those with Philips xPAP systems older than 5 years, or with non-DreamStation systems, instead of being 12 months from the June 2021 announcement, those folks could now be waiting longer than 12 months and from September 2021.  From an April 2021 disclosure, folks with older recalled Philips device may not see a "fix" now until 2023 - almost 2 years later, notwithstanding the more recent reports that Philips has known about the faulty foam issues well prior to 2021.

[btreger]

RE >HME News Article<

WakeUpTime did a very good job of summarising the article. He did however leave one important new fact out. 

Back in November, the FDA requested that Philips do further testing on their new replacement silicone foam.

In this article they provided an answer on where that new testing stands:


"Testing is also underway on the silicone-based foam that Philips is now using in replacement devices, per the FDA’s request" 

“I want to emphasize the silicone is safe and you can also derive (that) from the fact that the FDA said the recall and replacement can continue,” van Houten said. “I think it relates to a desire to have a strong rigor around this, but I want to emphasize that all of our own tests show that silicone is safe.”

[WakeUpTime]

<< above >>

Thanks for those additions.  

Maybe you could shed some light on something that confuses me.  The Philips CEO is only now saying that Philips will fix/replace some older devices; yet Philips initially had a vast number of older devices on its official Recall list - with Philips also later stating that the faulty foam even existed on other older devices not on its Recall list.  

How did this significant issue escape the FDA's watchful eyes, as well as the media - and perhaps even the lawyers in the class-action?  Following the Recall announcent, Philips seemed to only talk about DreamStation devices and devices less than 5 years old.  

I wonder who finally pushed them back on track?  Certainly it wasn't just the conscience of the Philips CEO.  The bad news though will be that older device owners may have to wait until 2023 to get a fix - that's a long time from first learning of the Recall in April 2021.  Many will have 'moved on' to another device by then anyway.  Perhaps Philips now concluded that it was legally better to replace the old decomposing foam in those devices, and clean the system chambers of all the foam particle bits.  Perhaps they wanted to avoid the headline, "Where did all my foam disappear to?", on some of those older devices.

[Kyteflyer]

Australia:  No idea where things are up to over here.  All I have had is an acknowledgement that I am entitled to something in relation to my DS, but that was months ago.  Nothing since then.  I’m not hopeful, and will likely move on as others have done.  I don’t have insurance to cover replacement, so its out of my own pocket.  Which is why I still also use (instead of the DS) my elderly Remstar pro auto.  Better than nothing.

[btreger]

Maybe you could shed some light on something that confuses me.  The Philips CEO is only now saying that Philips will fix/replace some older devices; yet Philips initially had a vast number of older devices on its official Recall list - with Philips also later stating that the faulty foam even existed on other older devices not on its Recall list.  

How did this significant issue escape the FDA's watchful eyes, as well as the media 

I think there is a least one plausible reason, that they wanted to get ahead of the FDA making them do it. In their thinking, this would make them look slightly more on the side of public health.

On the new recall list, they have added 2 Noncontinuous Ventilator's that I couldn't find on the initial recall list:

SystemOne 50 and 60 Series

[WakeUpTime]

Australia:  No idea where things are up to over here.  

Being from Australia, and following this thread, you might already have seen a previous post by btreger with the update link...

https://www.tga.gov.au/alert/philips-recall-action-cpap-bi-level-pap-devices-and-mechanical-ventilators

There's a Philips 1-800 number for Australia in there.  It's for setting up replacement devices but you could also challenge them with additional questions to see how they'll respond.  

There's also this under the section "Consumer and regulatory updates" (Australia):

Philips is responding to consumer requests for refunds. If you are not satisfied with the refund or reimbursement offered, you should request the offer be reviewed. You can do this via the Philips Electronics Australia Ltd support hotline on 1800 009 579.
In addition, you have rights under the Australian Consumer Law which are entirely separate to any remedy Philips may provide as part of this recall action. You can find more information on the Australian Competition & Consumer Commission (ACCC) website about your consumer guarantee rights(link is external).
The TGA does not administer consumer law. You can make a consumer complaint(link is external) to the ACCC if you experience difficulties asserting your rights regarding the Philips products covered by this recall action.

I don't know if you've previously tried poking around those channels to see what they say these days, for Australians waiting for fixes/replacements.

[cathyf]

According to my DME, there are some insurance companies with policies that specify that the patient only gets a new machine if the old machine is NOT REPAIRABLE. To the stupid extreme sometimes, where the insurance pays more for the repairs than a new machine would have cost. My DME's RT told me that they have some patients with 15-20 year old machines who are FINALLY getting new machines because of the recall.

(For those of us in tech, we've been in this bureaucratic nightmare with computer gear, because computer gear gets better AND cheaper over time. 30 years ago the hubs had a computer monitor that had failed. This monitor had originally cost $1,800, to repair it would have cost $1,100, while a brand new equivalent monitor was $800. The problem was that there was a budget freeze, and no capital spending was allowed, but there was a repair budget. So the hubs called the company, explained the problem. The hubs shipped the company a broken monitor, and the company sent back a working monitor, and sent an invoice for $800 with the word "repair" on it.)

[TimaaaaaaaahRocks]

  a kind reminder or witness intimidation?

Dear Former Employee,


We are writing to you because you are a former employee who has had involvement in the development, testing and/or recall of Philips’ Continuous and Non-Continuous Ventilators, including the CPAP and BiPAP machines.  As you may have heard, there are ongoing products liability lawsuits concerning the Recall.  In connection with these litigations and any other possible related investigation, we want to alert you that someone could try to contact you and also of the availability of counsel.  We are therefore writing to make sure you know your rights and responsibilities if you are contacted.

Specifically, in some of the ongoing product liability litigation, it is possible that plaintiffs’ lawyers or plaintiffs may contact you as part of the process of gathering information related to the litigations.  Similarly, a government agency may also attempt to contact you to gather information. As a legal matter, you are under no obligation to cooperate or discuss anything with these lawyers, plaintiffs, or government agencies.  You are free to speak with a lawyer or a government investigator if they do contact you and to respond to his or her questions.  At the same time, you are not required to speak to them or provide any information except in a formal legal proceeding for which you receive a valid subpoena.  Otherwise, whether to speak to a government investigator is your choice alone.   

If you do choose to speak with a lawyer, plaintiff, or government investigator, any information you provide must be truthful and accurate.  Providing false or misleading information to a government investigator may itself be a crime. 

You also have the right to consult with a lawyer about whether to speak to a government investigator or how to respond to any subpoena, and to have a lawyer present if and when you do provide testimony or otherwise speak to these individuals.  As with your right to remain silent, whether to be represented by counsel is your choice alone.  In this regard, please also note that as a former employee, we request that you also contact the undersigned in Philips Respironics’ legal department. 

Keeping with Philips Respironics’ commitment to its employees, both present and past, if you are named in a lawsuit, or otherwise asked to provide information with respect to any lawsuit, Philips Respironics will provide and pay for legal representation for you, should you request or desire it.  If you would prefer to be represented by independent counsel, the company may be able to recommend counsel who could represent you, with the company paying the fees for that lawyer under certain conditions.

As you know, Philips Respironics stands behind all of its products and is committed to vigorously defend these lawsuits.  This commitment extends to the involvement of our former employees.  If you have any concerns or additional questions, now or at any time in the future, please feel free to contact either myself at 781-779-5673 or Lisa Dykstra of Morgan, Lewis & Bockius LLP at 215-963-5699.

 

Very truly yours,

 
Wendy Kunkle

Head of Legal

Philips RS North America LLC

1010 Murry Ridge Lane, Murrysville, PA 15668

781-779-5673 (cell phone)

wendy.kunkle@philips.com

[btreger]

RE>above<

Would we be wrong to assume this was sent to you Tim?