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

REGULATORY: VERIFY, VERIFY, VERIFY

Q. Can suppliers bill monthly rentals for Medicare patients with recalled Philips CPAP devices?

A. Yes, so long as the patient continues to use the device. Suppliers, however, should be increasingly diligent in their monthly verification procedures because the publicity surrounding the recall may persuade regular CPAP users to stop using their machines, even those produced by Philips’ competitors.


https://www.hmenews.com/article/regulatory
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Philips recalls, supply chain challenges dim 2021 outlook

Published Oct. 18, 2021

CEO Frans van Houten said third-quarter sales were impacted by a 150 million euro headwind due to the recall. While van Houten told investors that the company has "mobilized all necessary resources" for corrective actions, Philips is unable to reliably estimate the financial effect and potential associated liabilities.  


https://www.medtechdive.com/news/philips...ll/608381/
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(10-19-2021, 10:21 AM)SleepyCPAP Wrote: Just got this email from Philips Respironics today.  
I got the same email but I got mine 6 days ago..... odd.  I wonder why they didn't send them all the same day.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
If a site sends too many emails at once they can be marked as a source of spam...
Apnea Board Monitors are members who help oversee the smooth functioning of the Board. They are also members of the Advisory Committee which helps shape Apnea Board's rules & policies. Membership in the Advisory Members group does not imply medical expertise or qualification for advising Sleep Apnea patients concerning their treatment.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
FINANCIAL TIMES

Philips’ chief defends faulty component used in 10m products

The boss of Philips has said there was “no mistake in the design” of respiratory devices subject to a vast product recall, as he acknowledged that millions of more machines with the same faulty part have been in use beyond those summoned back for replacement by the manufacturer.

https://www.ft.com/content/0933b1c3-d185...OkHf22khSo
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(10-20-2021, 09:43 AM)btreger Wrote: FINANCIAL TIMES

Philips’ chief defends faulty component used in 10m products

The boss of Philips has said there was “no mistake in the design” of respiratory devices subject to a vast product recall, as he acknowledged that millions of more machines with the same faulty part have been in use beyond those summoned back for replacement by the manufacturer.

https://www.ft.com/content/0933b1c3-d185...OkHf22khSo

Sorry: I got to this link through Facebook. I only cut and pasted this one paragraph. I should have copied the entire article because I can not get back to the story without a subscription. It was posted in CPAP Reviews.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
That's seems like a somewhat disingenuous turn of phrase if ever I've heard one. Probably technically correct but I tend to wonder where he thinks the mistake was if not in the design...

-Neelix
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PHILIPS CEO
(10-20-2021, 09:43 AM)btreger Wrote: [FINANCIAL TIMES]  Headline: "Philips’ chief defends faulty component used in 10m products"

That's an excellent article.  Noteworthy additional excerpts including:

Quote:Philips is only replacing devices still in use within their lifetime, which is about five years in the US and longer elsewhere

That better not be true.  Many of the devices on the recall list were manufactured or began their use more than 5 years ago.  If this is now an issue, add another class-action lawsuit against Philips.  Also, if Philips says that its devices have a maximum lifespan of 5 years, they should have put an expiry date on the products or have hardcoded an expiration into their software.  Philips "recommended" that users upgrade, but I don't believe they ever said in the past that it was a requirement for continued safe use.

Quote:“no mistake in the design” of respiratory devices subject to a vast product recall, as he acknowledged that millions more machines with the same faulty part have been in use beyond those summoned back for replacement by the manufacturer.

 the company had used the polyurethane foam in its respiratory devices for decades — meaning more than 10m had used the foam

Add another class-action lawsuit for those devices that used Philips faulty foam that are not being recalled that may still be in-use today.  There may be additional compensation awarded to any users of those devices who later developed one of the cancers indicated as possible health effects related to the faulty foam - if they're still with us today.

Quote:Philips said it was “unable to reliably estimate” any legal liabilities.  However a wider pool of affected devices could increase the number of litigants should tests reveal that they cause patient harm.

third-party test results of the devices due in the fourth quarter

If I'm not mistaken, the fourth quarter is now through December 31st.

Quote:He [the Philips CEO] added that “the patient suffers and we very much feel for that. Apologies are due to patients”.

Actions speak louder than words.

And from an earlier news story also provided by btreger:

Quote:van Houten told investors that the company has "mobilized all necessary resources" for corrective actions

Political speak is something special.  When I first read that phrase, I thought it meant "we're doing everything possible".  Later, I realized that it didn't say that at all.  They could mobilize merely one person to work on the recall, if they felt that was the necessary resources.  The CEO's phrase actually says absolutely nothing.  That's pay well-earned by the Philips Public Relations Department.

I could say I've "mobilized all necessary resources" to become a billionaire, by purchasing a lottery ticket or changing jobs.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Thanks, WakeUpTime

This is the complete article:

Financial Times


The boss of Philips has said there was “no mistake in the design” of respiratory devices subject to a vast product recall, as he acknowledged that millions of more machines with the same faulty part have been in use beyond those summoned back for replacement by the manufacture.


The Dutch group is in the process of recalling approximately 3.5m devices primarily used to assist the breathing of patients suffering from sleep apnea, after detecting a faulty component in April.


The devices use a foam that can degrade and become toxic, putting investors on edge for a worst-case scenario of costly litigation reaching into billions of euros if the fault is linked to cancer. Thousands of patients believe they may have been harmed by inhaling particles or toxic chemicals.


But Frans van Houten, chief executive, told the Financial Times on Monday that the company had used the polyurethane foam in its respiratory devices for decades—meaning more than 10m had used the foam—arguing these met regulations at the time of production.


“We’ve been designing and producing ventilators for 10 to 20 years and we have been using this kind of foam forever. It was fully qualified by the rules, regulations, and standards at the time,” he said.


The devices are being tested to establish what compounds they release under what conditions, the toxicity of those compounds, and whether they cause cancer.


Philips is only replacing devices still in use within their lifetime, which is about five years in the US and longer elsewhere, at an estimated cost of E500m.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Continuation of the Financial News story:


A wave of class action suits has already been launched against the company in the US.

Philips said it was “unable to reliably estimate” any legal liabilities.

However, a wider pool of affected devices could increase the number of litigants should tests 
reveal that they cause patient harm.

Van Houten’s comments came as the group trimmed its annual outlook for sales growth to lowsingle-digits and a “modest” profit margin improvement, citing the device recall as well as a host 
of supply chain snags from semiconductor shortages to shipping bottlenecks.

Sales slipped 7.6 percent to €4.2bn in the third quarter compared with a year earlier, with 
“intensified” supply chain pressures expected to spill over into 2022, Van Houten said.

Shares in Philips were down 2 percent in lunchtime trading. They have slumped about a quarter 
since April, shaving about €10bn off the Dutch group’s market capitalization.

Philips cited a complaint rate of 0.03 percent of users based on 2020 data at the time of the 
recall but a larger number have been received since the recall, the group said.

“People will respond to that [the recall] and say ‘I want to put in my own complaint’. We’ve had 
a few thousand more than originally,” Van Houten said.

He said he had the full backing of the board: “The products were approved by the regulators. 
There was no mistake in the design of the product.” He added that “the patient suffers and we very much feel for that. Apologies are due to patients”

The group has so far produced 750,000 repair and replacement kits, of which a third have 
reached users, but supply chain issues mean that millions of devices cannot be replaced quickly.

Scott Bardo, an analyst at Berenberg, said he was hoping that the third-party test results of the 
devices due in the fourth quarter should ease investor fears around litigation.

“We are expecting an update from Philips’ in field studies in the coming weeks and believe that 
this could represent a positive asymmetric trigger for the stock,” he said
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