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

[SuperSleeper]

Has anyone sent back their replacement CPAP yet?

I have not.  Given it took nearly 2 years to get the replacement, and their lack of acknowledging emails I've sent in the past,  I haven't had much confidence that Philips would even acknowledge the return of my old DreamStation machine.  I'll just keep it for parts, or attempt to remove the foam myself.  I never signed anything saying I would return it, even if they sent a replacement.  All the return info was on their part.  I never agreed to any of their requirements, and receiving a replacement does not indicate any sort of "agreement" on my part, even if Philips "believes" that's the case.  I owe them nothing, especially since it was Philips who choose to risk the health of it's customers by using lower-cost sound-abatement materials to make more profits.

[KSMatthew]

I have not.  Given it took nearly 2 years to get the replacement, and their lack of acknowledging emails I've sent in the past,  I haven't had much confidence that Philips would even acknowledge the return of my old DreamStation machine.  I'll just keep it for parts, or attempt to remove the foam myself.  I never signed anything saying I would return it, even if they sent a replacement.  All the return info was on their part.  I never agreed to any of their requirements, and receiving a replacement does not indicate any sort of "agreement" on my part, even if Philips "believes" that's the case.  I owe them nothing, especially since it was Philips who choose to risk the health of it's customers by using lower-cost sound-abatement materials to make more profits.

Dream Station customers that bought a replacement (in my case, Resmed) AND received a replacement from Philips (in my case a DS 2), have been told they can get some reimbursement for their out of pocket expenses (the Resmed), but only if they send back the replacement that Philips sent (the DS2).  Sending back the recalled unit gets you into the $100 pool.

I eventually did send back my recalled DS, well after I got the replacement that I still haven't used.  It was taking up space so I went ahead and sent it back.  I ordered my Resmed about 2 days after the recall, just before all the DMEs raised prices on it.  The new arrangement says there will be a reimbursement for any out of pocket if you bought your own replacement.  But to get that you have to send back the replacement that Philips sent.  I still haven't seen anything definitive on just how much of a reimbursement there will be (100%?  50%?).

I was wondering if anyone has already sent back their 2nd Philips yet.

[Phaleronic]

I have sent back my bipapST and autobipap, haven't sent back the refurb'd apap they sent to replace my original apap (which I kept and remediated myself)..  We'll see how long it takes for the money to come back for the first two.

[btreger]

On Chrismas Day I posted this article:

PHILIPS 

Explained: Silicone sound abatement foam used in DreamStation 2 and the sleep and respiratory care devices remediated as part of the June 2021 Philips Respironics recall

Now ProPublica has picked up this story and posted this:

Philips Recalled Breathing Machines in 2021. Chemicals of “Concern” Found in Replacement Machines Raised New Alarm.

Though Philips has said the machines are safe, ProPublica and the Pittsburgh Post-Gazette obtained test results and other internal records that reveal for the first time how scientists working for the company grew increasingly alarmed and how infighting broke out as the new threat reached the highest levels of the Pittsburgh operation.

The findings also underscore an unchecked pattern of corporate secrecy that began long before Philips decided to use the new foam.

The company had previously failed to disclose complaints about the original foam in its profitable breathing machines, a polyester-based polyurethane material that was found to degrade in heat and humidity. Former patients and others have described hundreds of deaths and thousands of cases of cancer in government reports.

After the introduction of the new foam in 2021, this one made of silicone, the company again held back details about the problem from the public even as it sent out replacement machines with the new material to customers around the world.

One of the devices was the DreamStation 2, a newly released continuous positive airway pressure, or CPAP, machine promoted as one of the company’s primary replacements.

Alarm After Tests Find Chemicals of “Concern” in Replacement Philips CPAP Machines — ProPublica

[SuperSleeper]

Sending back the recalled unit gets you into the $100 pool.

Yep, I understand that's what they "say".  The old DreamStation is worth more than $100 to me for parts (my dad received a refurbished DreamStation as recall replacement), or as a back-up machine (once the foam is removed and the machine is fully cleaned).

And even if I did send the old unit back, I wouldn't be surprised if it takes over 2 years to get a check, if one comes at all.

Nope, I'll just keep the machine and let Philips do what it does so well (fail to deliver on their promises).  

[WakeUpTime]

[Published by Philips - December 22, 2023]
"Silicone sound abatement foam used in DreamStation 2 and the sleep and respiratory care devices remediated"
https://www.usa.philips.com/a-w/about/ne...ecall.html

Regarding foam and plastic chemicals, that's a common corporate statement these days - "meets existing health regulations."  Research studies often look for immediate noticeable harmful effects under highly controlled laboratory situations.  Few of those studies look at long-term "real life" situations, multiple variations in environmental conditions (temperatures, pressures, elevations, ages, etc.), interactions with other chemicals, effects under a magnitude of health conditions, long-term ever-changing dose levels of those toxins, and so on.  

I'm not a medical expert, but any gaseous, chemical or particle toxic compounds that are brought directly into one's lungs, especially under large volumes, high pressures, higher temperatures and humidity, likely present elevated health risks - especially amongst patients suffering from a variety of health conditions.

From a marketing perspective, they need to be working on a DreamStation 3.  From my significantly biased point of view, the DS2 looks like a futuristic shiny black coffin - even without knowing its lineage.  I'd switch out the extremely soft short-life latex+ for either nothing, or something much harder and more durable.  Sound might be louder, but sound engineers could completely redesign the inner airflow.  Hire some of those Bose engineers to solve that.

Philips has suffered considerably from a lack of executive oversight, which promotes an environment of "group think".  Its chain of command was significantly threatening to a continuous quality improvement methodology.  In short, Philips' top management, in their inability to focus on anything other than stock price, ended up costing the company billions of euros.  Breakthroughs happen when companies ask independent non-incentivized users "what do you think?"  That's not accomplished by merely sending out free devices to pro-Philips DMEs and end-users.

College business schools across the country should include Philips in their case studies as a way of reminding future business managers of how to avoid losing everything by ignoring or disrespecting the end-user.

[WakeUpTime]

"Chemicals of “Concern” Found in Replacement Machines Raised New Alarm"
December 28, 2023
https://www.propublica.org/article/phili...of-concern

Philips said it proposed a limit used by the World Health Organization to provide a “harmonized” threshold at the company’s testing labs.  That threshold allows for far higher formaldehyde emissions than benchmarks used by other organizations, including the Environmental Protection Agency.

Experts who reviewed the test results for the news organizations said the findings revealed troubling markers, including the presence of formaldehyde at levels that exceed safety thresholds established by multiple organizations. Thresholds vary, they said, and those cited by Philips allow for far higher formaldehyde levels than others.

So basically, it's something like... "we've been failing independent tests done by the media so let's stick to an overly generous chemical safety standard and select a friendly obedient lab facility of our choosing".  And after getting a new passing grade:

“Great news. … They are updating all of their reports accordingly,” Faulk wrote. “A big win for the team!”  In its statement, Philips said it proposed a limit used by the World Health Organization to provide a “harmonized” threshold at the company’s testing labs.

[chasmm]

Has anyone else received more copies of the settlement paperwork than they have defective machines? I have three machines under recall (DS1, DS Go, System One) and I've gotten six (6) copies of the settlement agreement. I don't see anything that ties the paperwork to the individual machines. The Confirmation Codes and/or Claim IDs don't match either my return Confirmation Codes or my Serial Numbers.

I'm assuming this is just another glitch in the Philips response, but was wondering if this has happened to anyone else...

[btreger]

Pittsburgh Post-Gazette


Philips recall crisis casts a shadow over legacy of Respironics founder
CPAP inventor Gerald McGinnis says the recall is a 'disappointment and embarrassment'

The founder of Respironics, who had been widely credited for creating the first mass-produced breathing machine in the United States, had discovered that another of his inventions had a serious flaw.

That year, Mr. McGinnis met with his engineers from Murrysville headquarters. Then he ordered all 50,000 BagEasy devices — the second recall of the masks in as many years — pulled from the shelves.

But it was also an event that defined the way he ran his company, which grew to 4,900 employees and more than $1 billion in sales by 2007 — the year that the Dutch conglomerate Royal Philips swept in with an irresistible offer.

Sixteen years after Royal Philips bought his company and renamed it Philips Respironics, Mr. McGinnis said he struggles to make sense of a new crisis that threatens to overshadow the legacy he built for nearly a half-century.

In 2021, Philips pulled millions of CPAPs and ventilators off the shelves after it was found that foam placed in the devices could degrade into tiny particles and fumes, and potentially send toxic chemicals into the respiratory systems of users.

The revelations about the company's handling of defects have left Mr. McGinnis fearful that patients will lose faith in a critical area of medicine he once championed.

In an extensive interview — his first in the aftermath of the recall — the 89-year-old engineer described his profound disappointment in what happened to the brand that he created as well as concerns about company practices that risked the safety of millions.

“If you hurt somebody, the game is over,” he said. “You’ve got to take responsibility.”

Philips CPAP recall casts shadow over legacy of Respironics founder Gerald McGinnis | Pittsburgh Post-Gazette

[btreger]

DreamStation 2 Formaldehyde BOMBSHELL

Nicko Dundai does a YouTube video on this story I posted yesterday:

DreamStation 2 Formaldehyde BOMBSHELL! (youtube.com)