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

[WakeUpTime]

That said, it's shameful that you haven't been alerted by your dme.

I'm really not an apologist for Phillips, but...they will need to contact, what, half a million people? and they don't have all those records by any means. Most don't buy their machines directly from Phillips. How would they have one's email or phone number?

I, too, have not been notified by any of my DME providers on the Philips recall.  I've purchased two Philips systems from two DMEs.  No calls/mail/e-mails regarding the recall.  I've purchased supplies from another 2-3 DMEs, who have my prescription on-file and my Philips PAP system information stored.  No notification from them either.  Not even any notification from my sleep center.  Nothing, zero.  

Regarding Philips having end-user details, as a medical restricted device, one would think Philips would request end-user details from each DME after each sale, at least for the purpose of Philips' warranty coverage.  No, not Philips.  One would think Philips would have immediately instructed all authorized DMEs to immediately notify all Philips' system users of the recall.  It doesn't appear that Philips instructed them to do that - at least from my perspective.

Lastly, we've had no individual response from Philips after registering at the recall site.  Nor have we received an update of what's coming.  You'd think they'd merely confirm our e-mail addresses as an absolutely minimum, but no, Philips won't do that.

So, it would seem that Philips has failed miserably in getting any notifications of any kind to end-users.

[S.Thompson]

Whoa Btreger! GREAT idea! Thanks so much for thinking of it and sharing! 
Document. Document. Document. 
That's the name of the game in everything.

[racprops]

"S.Thompson
“No Rich. Medicare Advantage HMO plans do NOT consider your machine paid for and yours after 13 months. Mine specifies quite emphatically that it is not mine... EVER, unlike regular Medicare.”

Oh well, I am on Regular Medicare, so mine was paid for.

I did say as I understand: most insurance.

Rich

[glenlyon602]

A few thoughts:

The video on Philips’ latest information sheet for DMEs says Philips has relied on two published studies to alert them to this issue.  But the bibliography says these articles were published in 2011 and 2014.  How will they explain the delay in becoming concerned?

Since customers have not been notified by Philips that there is a recall, isn’t the fact that 1 in 15 or so customers have already registered remarkable, just by hearing about this second hand?

I feel that DMEs and the doctors are inevitably going to be dragged into the coming litigation. The response of many DMEs seems to be utter silence or “call your doctor.”  The response of many doctors seems to be utter silence or “call your DME.”  While the doctors and clinics will have insurance, I wonder if many of these little mom-and-pop DMEs will fold as their owners shift assets out of the companies and then pray the storm will pass over them.

[WakeUpTime]

The news media is beginning to report on the state of confusion and frustration amongst Philips recalled system owners:

"Philips CPAP Recall Leaves Sleep Apnea Patients in Confusion"
July 14, 2021

The company says it has received reports from users who felt sick and found black particles of the insulation material inside their CPAP machine’s air path tube. However, there have not been any consumer reports of exposure to the chemical emissions, and none of those sickened by the particle emissions have died.

The recall affects an estimated three to four million Philips CPAP-type devices globally. Over half of the devices were sold in the US by the company’s Pennsylvania-based Respironics subsidiary, mostly under its DreamStation brand name. The recall only affects the first-generation Dreamstation machines. The newer model Dreamstation 2 machines are not affected by the recall.

While Philips has promised to fix the problem for all its affected machines already in use, it has not yet announced how the recall will work or how long it will take for all of them to be repaired or replaced. Meanwhile, the company is sending letters to all users of the affected machines asking them to register them online to get their machines repaired or replaced, or to call Philips at 877-907-7508.

Industry observers predict that a shortage of new CPAP machines is likely to develop quickly as word of the recall spreads and affected users seek replacement machines from Philips or other CPAP machine manufacturers.

"Philips CPAP, ventilator machine recalls leave patients unsure what to do"
Massive medical device recall leaves patients unsure what to do
July 9, 2021

"Philips Recalls CPAP Machines for Cancer Risk Linked to Toxic Foam"
Philips recalled millions of CPAP machines because users can breathe toxic foam that can cause cancer or other health issues.
July 8, 2021

Philips has recalled around 4 million breathing machines because users can breathe tiny particles of toxic cancer-causing foam.  Philips said no one has died yet, but some users have reported suffering from headaches, airway irritation, coughing, chest pressure and sinus infections, according to the Medical Device Recall Notification.

The problem is linked to a type of black foam known as Polyester-Based Polyurethane (PE-PUR), which can disintegrate into tiny particles or toxic gases that users breathe.  Philips designed the breathing machines with this toxic foam inside the same tube that carries the air that a user breathes.  On newer machines, Philips did not change this problematic design. Rather than sealing off the foam from the air a user breathes, the company simply switched out the type of foam in the tube.

Health risks linked to the toxic foam include cancer, organ damage, liver and kidney failure, asthma, sinus infections, and more.  Testing by Philips also discovered that the foam can “off-gas” toxic chemicals, releasing dangerous Volatile Organic Compounds (VOCs).  The health risks of breathing bits of foam include “irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver,” according to the FDA recall notice.  The FDA also warned that health risks of breathing toxic gases from the foam include “headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects.”

Philips said these risks increase when the foam is exposed to high heat or humidity, or unapproved cleaning methods, such as ozone.  Unfortunately, many patients who rely on Philips’ recalled breathing machines have been left in the lurch.

[Deborah K.]

EXCITING NEWS FOR THOSE ON MEDICARE!

After reading rbuckles' post in another thread about the possibility that Medicare may be willing to supply new pap machines to those whose machines are part of the Philips recall, I called United Healthcare with whom we have a brand new Medicare Advantage PPO policy. They researched a little then told me that yes, it's true.  The wonderful woman assisting me called my DME on a three-way phone call and we got it all arranged.  My husband and I will both be receiving Resmed Airsense 10 machines as soon as they have them back in stock.  I'm so happy!!!

P.S. Neither of our machines is old enough to be replaced in the ordinary course of things.

[Gideon]

Which of the 4 ResMed AirSense 10 machines are you getting? You want either the ResMed AirSense 10 AutoSet or the AutoSet for Her.

[Deborah K.]

Thank you Gideon.  I hope to get either of those for both of us.  The DME said they have them on order, and the For Her version may not be available for a longer time.  I'd prefer the extra algorithm, but maybe it's not a deal-breaker.  Do you think I should wait for those or take the not for her version if they come in sooner?

[hegel]

wakeuptime: what are you quoting from? the links don't link to any source. please indicate your sources.

p.s. Deborah: great news! it makes sense that it may take a little time for various agencies (medicare etc.) to figure out how to respond to all this. They have other matters to deal with as well.

[SarcasticDave94]

Get the ResMed AutoSet, it'll be fine without the For Her setting.