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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(07-26-2021, 04:54 PM)hegel Wrote: Btreger, your methodology is flawed and so the conclusions you draw are mere speculation.  

You may have missed the rest of my post where I questioned whether all of those complaints will turn out to be related to PR machines. People with health issues will assign all sorts of causes to their troubles; often, they misdiagnose the actual source.

I see no reason to cause unnecessary anxiety. I'll wait for actual research or at least accredited sources using more accurate measurements. Always extrapolating to the worst case seems silly, frankly. In one of the videos put out by a provider that appeared here some pages ago, the speaker said they had had 2 complaints over the years about black particles in PR machines--out of many thousands sold. He wasn't a PR guy, but just trying to assess what we know. So maybe we haven't heard about complaints before now--because there have hardly been any. In other words, there's a chance that news is better, not worse, than we guess or imagine. Maybe we end by breathing a sigh of relief rather than in anguish and despair and anger and grievance.

Maybe you should tell these people, "Since the recall was announced, the FDA has recorded more than 1,200 complaints and over 100 injuries related to the issue", they are all suffering from unnecessary anxiety. This is one month of reports that the FDA has released. "Maybe we end by breathing a sigh of relief rather than in anguish and despair and anger and grievance". I think most people on this thread are getting a little tired of being told to go sit in the corner, don't think for yourself, and of course don't worry about your health, this will all blow over and everyone will just be fine.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Philips’ chief plays down litigation risk over faulty component

The head of Royal Philips has played down the litigation risk over the discovery of a defective component in some of the medical technology company’s sleep and respiratory devices.


The fault has shaved almost €10bn off the Dutch group’s market capitalisation as shares have plunged more than 20 per cent since April when the defective part was discovered. Shares fell a further 4 per cent to €39.06 on Monday.

Although investors feared hefty litigation charges would follow a string of impairments totalling €500m, Frans van Houten, chief executive, said only 10 patients had reported mild health issues.

The issues stem from foam used in its devices that may degrade and risk exposing patients to harmful particles and toxic chemicals.

 “None of them have reported serious health issues. We should not get carried away on the risk of litigation,” he told the Financial Times. It was “way too early to come to any assessment” on estimates of the sums involved in any potential settlements.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(07-27-2021, 09:10 AM)btreger Wrote: The fault has shaved almost €10bn off the Dutch group’s market capitalisation as shares have plunged more than 20 per cent since April when the defective part was discovered. Shares fell a further 4 per cent to €39.06 on Monday.

Although investors feared hefty litigation charges would follow a string of impairments totalling €500m, Frans van Houten, chief executive, said only 10 patients had reported mild health issues.

<additional to above news posting>

Quote:Reuters
July 26, 2021

Philips has now set aside 500 million euros for the machines, but the threat of litigation in the United States is giving investors nightmares. The company’s market value has fallen by roughly 10 billion euros since Philips disclosed the issue in late April. That’s more than 10 times the unit’s entire annual sales of 600 million euros to 700 million euros. Even so, a further 2% drop in Philips shares on Monday morning suggests van Houten faces more restless nights.
Philips sleep fail gives investors recall insomnia | Reuters
US$12 Billion in Philips stock loses
US$600 Million in preliminary cost allocations by Philips

Philips doesn't seem to be handling this well for end-users, DMEs and stock owners.  I wouldn't be surprised if the Philips Board eventually replaces the CEO.  An internal investigation may also be initiated to see where Philips went wrong.

Quote:
Philips has currently lost approximately US$3,150 per recalled device.
Philips initially estimated recall costs of US$170 per device (500M Euros, 4M recalled devices).


Philips could have achieved a much better industry reputation by immediately announcing a defective system buyback.  Instead, the Philips CEO chose a strategy to merely replace the faulty devices with a (est. $1/device) piece of new foam and related service costs.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Frans van Houten, CEO: April 26,2021


Regretfully, we have identified a quality issue in a component that is used in certain sleep and respiratory care products, and are initiating all precautionary actions to address this issue, for which we have taken a EUR 250 million provision.

 

Regulatory update
 
Philips has determined from user reports and testing that there are possible risks to users related to the sound abatement foam used in certain of Philips' sleep and respiratory care devices currently in use. The risks include that the foam may degrade under certain circumstances, influenced by factors including the use of unapproved cleaning methods, such as ozone [1], and certain environmental conditions involving high humidity and temperature. The majority of the affected devices are in the first-generation DreamStation product family. Philips’ recently launched next-generation CPAP platform, DreamStation 2, is not affected. Philips is in the process of engaging with the relevant regulatory agencies regarding this matter and initiating appropriate actions to mitigate these possible risks. Given the estimated scope of the intended precautionary actions on the installed base, Philips has taken a provision of EUR 250 million.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(07-27-2021, 09:55 AM)btreger Wrote: Frans van Houten, CEO: April 26,2021


Regretfully, we have identified a quality issue in a component that is used in certain sleep and respiratory care products, and are initiating all precautionary actions to address this issue, for which we have taken a EUR 250 million provision.

 

Regulatory update
 
Philips has determined from user reports and testing that there are possible risks to users related to the sound abatement foam used in certain of Philips' sleep and respiratory care devices currently in use. The risks include that the foam may degrade under certain circumstances, influenced by factors including the use of unapproved cleaning methods, such as ozone [1], and certain environmental conditions involving high humidity and temperature. The majority of the affected devices are in the first-generation DreamStation product family. Philips’ recently launched next-generation CPAP platform, DreamStation 2, is not affected. Philips is in the process of engaging with the relevant regulatory agencies regarding this matter and initiating appropriate actions to mitigate these possible risks. Given the estimated scope of the intended precautionary actions on the installed base, Philips has taken a provision of EUR 250 million.
Philips has taken a provision of EUR 250 million. That number is reported to have doubled to EUR 500 million.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Interestingly, although the company seems to have set aside €500 million to address the concerns of users, they've set aside €150 billion to buy back some stock to ease the concerns of investors. 

That right there lets you know where their priorities lie.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I agree that Philips could have salvaged their industry reputation by immediately announcing a defective system buyback rather than attempt to dance round the issue.
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PHILIPS RESPONDS TO Q2 FINANCIAL RESULTS
"Philips’ CPAP recall dents second quarter connected care sales"
BioTech News / July 26, 2021

Currently, the company is conducting further research and tests to establish the full scope of patient risk and has established dedicated customer support centers while registering more than 2.2 million active devices.

“We fully understand the impact that this is having on patients,
as their well-being is at the heart of everything we do at Philips” 
[Frans van Houten, Philips CEO]

[?]

[*NOTE: Philips has to-date provided end-users with no results and no communications, following their request for registrations.  Philips is not corporately structured to allow for patient communications and other interactions.  Philips' customers are DMEs and other medical agency purchasers - not end-user patients.  Most patients on the other hand, through no assistance from Philips, are required to purchase replacement devices.]

“We are in discussions with the relevant regulatory authorities to obtain authorization
to start deploying the repair kits and replacement devices that we are producing.”

Last week, the FDA gave the recall its Class I label, the agency’s most serious, and urged patients to stop using the devices immediately and contact Philips to replace the component. Meanwhile, regulators in the E.U., U.K. and Japan have advised patients to consult with clinicians before altering their therapy.

The recall affects nearly two dozen models manufactured between 2007 and this year. More than 1,200 complaints have been filed with the FDA, with at least 100 injuries linked to the foam particles, the agency said.

By the end of this year, Philips said it aims to triple its ability to manufacture repair kits and replace units, ramping up to 80,000 per week.

[*NOTE: That alone, notwithstanding shipping and service times, would require at least 12.5 months from manufacturing and replacement programs, for 4 million devices.]
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Does anyone know the model# or info for the hose end filter that might help prevent foam bits from working their way through?

Edit, never mind, pretty sure I found them
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
It will be helpful to everyone to have at one place a collection of everything known about the foam particles along with relevant information from the fields of particle science, air pollution science and aerosol science.

The subject is deep and wide, but not insurmountable. We can learn much from the minimal disclosures by Philips and various regulatory authorities.

My question to all is where should such a resource be placed? Here? In a new thread? In a wiki? As an addition to the existing wiki about the recall?
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