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

[btreger]

I totally appreciate you posting links to pertinent news, but does the synopsis at the end always have to spiral into a conspiracy theory?

Can we just stick to the facts instead of trying to enflame the situation further?

I am honored that you appreciate my posting pertinent news. I did not even know that you closely monitoring what I was doing. The thing is that pertinent may mean something totally different depending on who is reading it. The rules of the forum are fairly simple, this might even make sense to you;

INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.

Please do not respond, period!

[btreger]

NBC Connecticut

CPAP Machine Recall Leaves Sleep Apnea Patients Wanting Answers
By Shannon Miller • Published 43 mins ago • Updated 21 mins ago

“They're proposing some potential toxic or cancer forming developments down the road, but we just don't know it's too soon to understand that,” Dr. Jeff Nascimento said.

Nascimento, a pulmonologist with Hartford Healthcare Medical Group, recommends patients with more moderate to severe sleep apnea to continue using the CPAP machine until they can get a new device and for those with a milder case of the disease to stop using the machine for now.

“At this point, we're just waiting to hopefully, get more influx of these devices so that patients can get replacements and they don't have to worry about the potential harm to them,” Nascimento said.

“We’re continuing to put a tremendous amount of pressure on them,” Connecticut Attorney General William Tong said.

https://www.nbcconnecticut.com/investiga...s/2587365/

[mrmagloo]

Clearly you have alot of free time on your hands.  Yes, the news is great.  Thank you.  The crazy conspiracy theories are not.

The clear objective of this specific thread is to present FACTS to the members and passersby regarding the Philips Recall situation.

[btreger]

TORONTO | News

Canadians with sleep apnea frustrated over CPAP machine recall
Published Tuesday, September 21, 2021, 6:10 PM EDT

TORONTO -- An estimated two million Canadians suffer from sleep apnea and those who use a Philips brand machine to help them sleep are frustrated that they could have to wait up to a year for repairs or replacement.

https://toronto.ctvnews.ca/canadians-wit...-1.5594980

Note: In the last two posts I submitted were news reports that were both created today. There wasn't anything new about them as far as facts, but it was nice to see that our story is still being broadcasted. We have gone several weeks without any new news.

The only real story we have seen is the excellent job WakUpTime has been doing in tracking and documenting all the new DS2 machines that have been received by members of this thread.

[WakeUpTime]

<< above article >>

"Philips added it is producing repair kits and replacement devices in large quantities and has increased the production capacity of repair kits and replacement devices in the third quarter of 2021 to 55,000 per week, aiming to further increase that capacity to 80,000 units per week in the fourth quarter of 2021."

The news media clearly doesn't understand the recalled device replacement process, in merely quoting the standard press releases from the Philips Public Relations Department.  A good news writer would pressure Philips to estimate the starting date, and the repair rate, of all other devices besides the DreamStation 1 CPAPs and APAPs including:

• DreamStation 1 BiPAP
  
• DreamStation 1 BiPAP AutoSV
  
• System One Series 50 and 60 System Models
  
• Older Respironics Series Models
  
• etc.
  

For the news media, replacement foam kits equals updated devices for the above recalled device owners, when that's clearly not the case.  Philips is getting away with providing a combined total manufacturing of new DreamStation 2 CPAP/APAP units (for those getting replacement devices) and newly manufactured foam pieces while avoiding providing the above device owners with any estimated service repair dates.  Hopefully, the FDA will also see that and force Philips to release those details, at least to the FDA.

[btreger]

FDA CPAP RECALL UPDATES

Is Philips replacing recalled CPAP machines?

On 8/26/2021, Philips confirmed they are replacing some high-risk CPAP users' machines with DreamStation 2, which is not on the recall list. At the same time, they are redirecting all the production to the DreamStation with the new foam. ... However Philips' new sound abatement foam is still under FDA approval process.


So if this is accurate, Philips is replacing high-risk users with DS2 machines with the new foam that has not been approved yet as of 8/26.

Earlier this month the FDA said it gave Philips permission to ship the new DS2 machines. The new foam was never specifically mentioned.

The FDA could have had the new foam tested and just did not mention it.

I do not know that answer because it is not documented anywhere I have access to.

[WakeUpTime]

It might be a good idea to add btreger's earlier posting of details from the FDA Q&A as a line item to gideon's Philips Recall Wiki.  The FDA seems to be updating that page over time so the link should be consistent.  

Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions
https://www.fda.gov/medical-devices/safe...-questions

And many 'thanks' to btreger for his continuous research.

It's always interesting to read about the FDA's official responses.  Of course, there's often a disconnect between what they state and reality.  Here's my favorite:

Q: I have registered my recalled device on the Philips Respironics website. What should I expect now? (Updated 9/10/21)

A: Philips Respironics should keep you informed of their progress in addressing the issue and alert you to any actions that you may need to take.  

[HairyReasoner]

FDA CPAP RECALL UPDATES

Is Philips replacing recalled CPAP machines?

On 8/26/2021, Philips confirmed they are replacing some high-risk CPAP users' machines with DreamStation 2, which is not on the recall list. At the same time, they are redirecting all the production to the DreamStation with the new foam. ... However Philips' new sound abatement foam is still under FDA approval process.


So if this is accurate, Philips is replacing high-risk users with DS2 machines with the new foam that has not been approved yet as of 8/26.

Earlier this month the FDA said it gave Philips permission to ship the new DS2 machines. The new foam was never specifically mentioned.

The FDA could have had the new foam tested and just did not mention it.

I do not know that answer because it is not documented anywhere I have access to.

The foam was approved in the FDA approval earlier this month.  Per Philips September 1st announcement about the FDA approval:

"Philips received authorization from the US Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation devices [1], which consists of replacement of the PE-PUR sound abatement foam with a new material. Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices. Philips remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the US."

So, the September 1st approval was not regarding permission to ship new DS2 machines.  That was already occurring prior to September 1st (Philips didn't need further approval for that because the DS2 machines were already FDA approved).  The FDA approval was specifically related to the foam and Philips' recall plan for the Dreamstation 1 units.

[archangle]

My unverified impression is:

DS2 with the foam it uses was approved pre-foamgate.  

"DS2" foam is not the same material as foamgate foam and is not believed to be hazardous to users of DS2 machines. 

There is a "retrofit" foam that may or may not be the same as "DS2" foam.

Replacing the foam in DS1 or PRS1 machines with a different foam material requires/required FDA approval.  Even using the same foam as the DS2 foam material requires FDA approval before it can be used to retrofit machines subject to by the recall.  This is true even if the FDA does not consider the foam to be hazardous.

FDA CPAP RECALL UPDATES

Is Philips replacing recalled CPAP machines?

On 8/26/2021, Philips confirmed they are replacing some high-risk CPAP users' machines with DreamStation 2, which is not on the recall list. At the same time, they are redirecting all the production to the DreamStation with the new foam. ... However Philips' new sound abatement foam is still under FDA approval process.


So if this is accurate, Philips is replacing high-risk users with DS2 machines with the new foam that has not been approved yet as of 8/26.

Earlier this month the FDA said it gave Philips permission to ship the new DS2 machines. The new foam was never specifically mentioned.

The FDA could have had the new foam tested and just did not mention it.

I do not know that answer because it is not documented anywhere I have access to.

[HairyReasoner]

My unverified impression is:

DS2 with the foam it uses was approved pre-foamgate.  

"DS2" foam is not the same material as foamgate foam and is not believed to be hazardous to users of DS2 machines. 

There is a "retrofit" foam that may or may not be the same as "DS2" foam.

Replacing the foam in DS1 or PRS1 machines with a different foam material requires/required FDA approval.  Even using the same foam as the DS2 foam material requires FDA approval before it can be used to retrofit machines subject to by the recall.  This is true even if the FDA does not consider the foam to be hazardous.  


I think you are correct.  According to Philips CEO's statement in the 2nd quarter earnings call, the foam in the DS1 had been FDA approved at the time the DS1 was approved.  Then, the standards changed so the DS1 foam was no longer in compliance.  However, a grandfather clause in the law still allowed it to be used in the DS1s.  But, they had to use new foam when they designed the DS2, since it was not under the grandfather clause.  That was fine until they started to have reports of the DS1 foam breaking down.  It was those reports that triggered the recall.  So, the DS2 does use foam that was approved prior to foamgate.  It isn't clear if the foam they are retrofitting into the DS1s as a part of the recall is the same as the DS2 foam, but it would seem to make sense it is.