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

[WakeUpTime]

Just be glad Philips has the money to fix the machines and move on.

If that were the case, this thread would only need to be one page, and one post.

There are more than a few people who are not satisfied with merely waiting 6-18 months for a replacement to their disintegrating carcinogenic off-gassing foam in their faulty designed Philips medical device.  

Also, there's much more at stake than merely replacing the foam:

• how much foam have we individually ingested?
  
• how much foam have others ingested? (SoClean users, non-SoClean users, DS1 users, System One users, BiPAP vs. CPAP, etc.)
  
• how have some users, including those with compromised health conditions, had their health impacted by their choice of a Philips xPAP vs. others?
  
• when did Philips internally first know about the disintegrating foam?  
  
• why didn't Philips postulate that the foam would eventually break down?
  
• why did Philips choose/accept the chemicals used in its foam, and not choose similar foam designs in other competitor's PAP systems?
  
• why is it taking Philips 12+ months (more like 16+ months since first learning of the issues) to fully replace faulty systems?
  
• etc.
  

Philips 3rd Quarter Financial Report:

As disclosed in its Q2 2021 report, Philips is a defendant in a number of consumer class action lawsuits from users of the affected devices and a number of individual personal injury claims. Given the uncertain nature and timing of the relevant events and potential associated liabilities, if any, the company is unable to reliably estimate the financial effect of these matters. 

Frans van Houten, CEO:
“I am pleased with the strong double-digit comparable order intake growth in the third quarter, driven by both the Diagnosis & Treatment businesses and Connected Care businesses. Our strategy and portfolio are highly relevant to our customers, as we help them transform the delivery of care along the health continuum. Building on this strength, we have signed an additional 19 long-term strategic partnerships with hospitals across the world, including a 10-year partnership with Baptist Health in the US to provide patient monitoring solutions and standardize care across the network.

We recorded EUR 4.2 billion sales in the quarter (est. US$5 billion), with a 7.6% comparable sales decline on the back of 10% comparable sales growth last year. This quarter’s sales were impacted unfavorably by intensified global supply chain issues, such as the shortage of electronic components, and the anticipated revenue consequences of the sleep recall, as we are prioritizing the remediation of affected devices in use by patients. The Adjusted EBITA margin was 12.3%.

[Note: Philips has allocated approximately 10% from its gross sales from merely ONE QUARTER to deal with the recall.]

The repair and replacement program related to the sleep recall notification is under way in the US and several other markets. I am conscious of the impact this is having on patients and care givers, and we are doing everything we can to deliver a solution as fast as possible.

We successfully completed the sale of the Domestic Appliances business, resulting in a gain of EUR 2.5 billion. With this, we concluded our major divestments, allowing us to focus fully on extending our leadership in health technology and continuing our transformation into a solutions compan

https://www.results.philips.com/

[ST Dog]

If that were the case, this thread would only need to be one page, and one post.

There are more than a few people who are not satisfied with merely waiting 6-18 months for a replacement to their disintegrating carcinogenic off-gassing foam in their faulty designed Philips medical device.  

Possibly disintegrating possibly carcinogenic possibly off-gassing foam

Lots of machines have been opened an found not degradation.

Nothing about how much of what chemicals are off-gassing when they are. Is it enough to be a real concern for the average users? If so, over what time period.

Under what conditions is the off-gassing even happening? Only if breaking down? Before then?

[*]when did Philips internally first know about the disintegrating foam?

 
Would like to know that.

[*]why didn't Philips postulate that the foam would eventually break down?

All foam eventually breaks down yet no manufacturer says anything about that.
And the breakdown depends on many variables. I one case it might be 5 years in another it might be 20.
Same foam, just different environments.

[*]why did Philips choose/accept the chemicals used in its foam, and not choose similar foam designs in other competitor's PAP systems?

I'm not convinced they didn't. We don't know what was used by Philips and we don't know what was used by others at the same time. So no way to tell how similar they are.

ResMed said they used a different foam, but they didn't say what foam they used.
And we've seen reports of foam breakdown in ResMed machines.
For example https://www. a DME-owned forum .com/viewtopic.php?t=177081

[btreger]

I'm not convinced they didn't. We don't know what was used by Philips and we don't know what was used by others at the same time. So no way to tell how similar they are.

Maybe you should take some time and read what Philips actually said. You might learn something, or maybe not!

Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices

To date, Philips has produced millions of Bi-Level PAP, CPAP, and mechanical ventilator devices using the PE-PUR sound abatement foam. Despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. 


https://www.usa.philips.com/a-w/about/ne...vices.html

[cathyf]

There are more than a few people who are not satisfied with merely waiting 6-18 months for a replacement to their disintegrating carcinogenic off-gassing foam in their faulty designed Philips medical device.  

Also, there's much more at stake than merely replacing the foam:

• why is it taking Philips 12+ months (more like 16+ months since first learning of the issues) to fully replace faulty systems?
  
• etc.
  

Somehow the most bemusing thing that I find about the whole trainwreck is their oh-so-casual suggestion to patients that they shouldn't sleep for a year...

[ST Dog]

Maybe you should take some time and read what Philips actually said. You might learn something, or maybe not!

I did read it and I read what ResMed said and what DeVilBiss said too.

But nobody knows exactly which foam was used by any manufacturer. They gave broad categorical types, but not specific foams.
I can go buy a dozen different foams of the type Philips mentioned and the type ResMed mentioned.

And I know that all foams deteriorate over time. I know users have reported particles in ResMed machines.

What we don't know is posted above, like what chemicals are released when the ResMed foams degrade, or how much of which chemical off-gasses on the Philips machines.

Philips came clean and is working to fix.

Others haven't came clean but they changed the foam used in their newer machines. Silicon based foam seems to be the go to now instead of polyurethane that was the norm for decades. Those old foams were all approved by the FDA as were the machines.

[btreger]

Philips came clean and is working to fix.

Those old foams were all approved by the FDA as were the machines.

Philips was told to do a voluntary recall or the FDA would issue a mandatory one, which they later did.

You keep bringing up ResMed. None of their products have been recalled, and there are no lawsuits against them. 

There are so many lawsuits against Philips, both civil and securities that the civil suits had to be bundled together so the courts could handle them. They are also facing lawsuits in other countries.

The FDA never approved any foams in any machines. Philips applied for deferred approval and was granted it. They then started manufacturing their product.

Remember this is the Recall Thread for Philips Dreamstation and System One Users  

[ST Dog]

You keep bringing up ResMed. None of their products have been recalled, and there are no lawsuits against them. 

The FDA never approved any foams in any machines. Philips applied for deferred approval and was granted it.

None yet. But other manufacturers use similar foam and gave similar issues with degradation. I expect recalls before long. Notice they are switching foams (or exiting the market)

Seems there's something bigger afoot and it ties to the Philips recall.


First I've heard of deferred approval. Searching found nothing. But that was 15+ years ago for the oldest machines recalled. And it was nevertheless approved in all the time since? Doesn't inspire confidence the FDA process.

[Neelix]

Seems the ResMed foam degrades if exposed to ozone but otherwise seems to hold its structural integrity pretty well. Also if I'm not mistaken, the air path for the AS10 is through a hole in the middle of the foam, as opposed to it going through the foam itself as seems to be the case with in the DreamStation teardown videos I've seen.

https://www.youtube.com/watch?v=150AUnfdY98

-Neelix

[btreger]

Fda Recall Cpap Machine | Contact Information Finder

Philips DreamStation CPAP Recall Updates (October 2021)

This site has links to many of the stories we have previously posted and are still questioning and discussing again.

https://www.webcontactus.com/fda-recall-...e/ex1:ez1/

[SleepyCPAP]

Just got this email from Philips Respironics today.  I’ve got two PRS1 CPAPs, each of them registered at the end of June.  I figure I’m at the back of the line, as neither was in warranty and I didn’t use ozone cleaners (though the 11-year-old machine does have decaying foam from age/heat, I don’t think they know that).  That’s probably why I’m only just now getting this:

“We are pleased to share an important update regarding your Philips device replacement. Philips received authorization from the US Food and Drug Administration (FDA) for the repair and replacement program for devices impacted by the June 14, 2021 recall notification*.

With this approval, we are initiating the repair and replacement program that puts patient safety and speed of resolution as the top priorities. Further, we have significantly increased our production, service and rework capacity to deliver replacement devices as fast as possible.

Also, we have learned of some fraudulent activity targeting patients impacted by this recall. We want to assure you that Philips will never ask for any payment or credit card information by phone or email.

Patient care is at the heart of everything we do at Philips. While we are starting to replace devices, in some cases, this process may take approximately 12 months. We will stay in communication with you regarding your replacement device. If you have already received a replacement device, please follow the instructions included in the box.

We appreciate your patience as we work towards a solution as fast as possible. Please visit  Philips.com/src-update for more information and answers to frequently asked questions.

As a reminder, your device registration confirmation number is 2021*********”