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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
MORE PHILIPS RECALLS
And yet another Philips Ventilator Recall? 

"Philips recalls more than 66K ventilators over power issue"
https://seekingalpha.com/news/3845612-ph...ower-issue
June 3, 2022

Quote:Philips is recalling more than 56K V60 and V60 Plus ventilators in the U.S. due to an internal power issue that may cause the machine to shut down unexpectedly, with or without a warning.  As of April 14, there have been reports of one death and four injuries related to the devices.  The ventilators were distributed between May 1, 2009 and December 22, 2021.  The U.S. FDA considers the recall a Class I, the most serious type.

"Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms"
[FDA]  U.S. Food & Drug Administration
June 3, 2022
https://www.fda.gov/medical-devices/medi...lator-stop
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Philips

If there is anyone interested in trying to communicate with the man in charge of their CPAP business, here is the info you would need;

Roy Jakobs
roy.jakobs@philips.com

Roy Jakobs is Executive Vice President and Chief Business Leader for the Connected Care businesses of Royal Philips. He is also a member of the Executive Committee of Royal Philips. Connected Care comprises the Connected Care Informatics, Monitoring & Analytics, Population Health Management, Sleep & Respiratory Care, and Therapeutic Care businesses.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
DreamStation Go Users

I just received this update from my DME, 

This is the Confirmation #provided to me by Philips.  It may just take some time to get these into their system and toes to the right people/companies.

On a related note, I can tell you Philips does not even have the FDA approval completed for the remediation process for the DreamStation Go.
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EVIDENCE PHILIPS KNEW FOR MANY YEARS + FOAM CAN BREAK DOWN IN ONLY ONE YEAR
"Philips Knew of CPAP Foam Decay Years Before Recall, Emails Show"
https://www.bloomberg.com/news/articles/...mails-show
Bloomberg
June 9, 2022
  • Company engineer told suppliers in 2018 about user complaints
  • Philips says 2021 recall came after board learned of problems
Quote:Koninklijke Philips NA knew about problems with noise-dampening foam inside some ventilators used for treating sleep apnea at least three years before issuing a US safety recall for the devices, newly unsealed court files show. 

A US-based company engineer disclosed that he’d gotten customer complaints about disintegrating polyurethane, which was making its way into the machine’s forced air stream, according to his email to a supplier. Amsterdam-based Philips faces about 300 lawsuits from users who say inhaling the foam particles poses a cancer risk. 

“The material sheds and is pulled into the ventilator air path,” Vincent Testa, a project mechanical engineer for Philips, said in an April 2018 email unsealed as part of consumer lawsuits overseen by a federal judge in Pittsburgh. “As you can imagine, this is not a good situation for our users,” Testa said. 

It wasn’t until June 2021 that Philips recalled 5.5 million Continuous Positive Airway Pressure (CPAP) machines and ventilators from the US market, after researchers linked the degrading foam to cancer and respiratory issues. The company has committed more than $800 million to the recall and repairs, but hasn’t disclosed estimates of litigation costs.

A company spokesperson, when asked about the unsealed emails, said that prior to 2021, Philips Respironics handled the complaints related to mechanical ventilators on a case-by-case basis. After Philips’ executive committee became aware of the issue and its significance in early 2021, the company issued a voluntary global recall notification to remediate the issue, the spokesperson said.

The US Food and Drug Administration has cited similar concerns. The agency said Philips had gotten more than 100 complaints about the decaying foam in the devices between 2014 and 2017, according to a May 2 letter the FDA sent to the company and made public on its website. 

Regulators found “sufficient evidence for FDA to determine there are reasonable grounds to believe the recalled devices that Philips manufactured after November 2015 were not properly manufactured with reference to the state of the art as it existed at the time,” the agency said in the letter.

“These unsealed emails make Philips look pretty bad” and may support claims by consumers that machines were sold “even though they knew for years earlier there was a problem with foam used in their design,’’ said Richard Ausness, a University of Kentucky law professor who teaches about mass torts.

Some of the suppliers, in their internal email discussions about Testa’s queries, said that if the foam were subjected to “high humidity,” it would “exhibit signs of hydrolysis in as short a time as a year,” unsealed court filings show. Hydrolysis is the chemical breakdown of a compound due to reaction with water.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Additional added information to WakeUpTime's post:

FIERCE Biotech

‘This is not a good situation’: Philips engineer flagged ventilator foam issues years before recall, court docs show
By Andrea ParkJun 10, 2022 11:23 am

Philips was aware of safety risks with the sound-abatement foam in many of its ventilators and knew that the foam was ill-equipped for that use several years before the company issued a formal safety warning to customers and began replacing the foam, newly unsealed court documents show.

Among the documents are several email exchanges between Bob Marsh, a technical director at Polymer Technologies—a distributor of Philips’ sound-abatement foam—and Lee Lawler, then the technical director of the polyurethane foam division at William T. Burnett, the maker of the foam. In April 2018, Marsh forwarded to Lawler a message from Vincent Testa, a mechanical engineer at Philips, who was seeking information about what would cause the material to break down.

“Recently we’ve received a few complaints from our customers that the foam is disintegrating,” Testa wrote. “The material sheds and is pulled into the ventilator air path. As you can imagine, this is not a good situation for our users.”

While sending Testa’s note to Lawler, Marsh referenced another message from 2016 in which he hadn’t identified Philips by name but mentioned that one of Polymer’s customers had received reports in the fall of 2015 of the foam breaking down after five years of use.

‘This is not a good situation’: Philips engineer flagged ventilator foam issues years before recall, court docs show | Fierce Biotech
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
MEDTECHDIVE

ResMed warns supply constraints may last 18 months after Philips completes recall of sleep-apnea devices
Published June 10, 2022

Dive Brief:

A ResMed executive warned at an investor event that the company is still struggling to meet the rise in demand for its sleep-apnea devices following Philips’ recall of millions of continuous positive airway pressure (CPAP) and ventilator machines.

Rob Douglas, ResMed’s chief operating officer, said Wednesday at a William Blair event that the supply-and-demand challenges could last for as long as 18 months after the completion of Philips’ recall. Douglas added that demand likely will outstrip supply until providers work through the backlog of patients that have built up amid the Philips recall, which began in June 2021 and has grown to affect about 5.5 million devices.

Despite ResMed’s struggles to meet the increased demand, William Blair analysts said they expect ResMed to achieve “durable market share gains, bordering on permanent” because of the recall. The analysts added in a Thursday analyst note that the worst-case scenarios for Philips’ Respironics are more likely.

ResMed warns supply constraints may last 18 months after Philips completes recall of sleep-apnea devices | MedTech Dive
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RE: EVIDENCE PHILIPS KNEW FOR MANY YEARS + FOAM CAN BREAK DOWN IN ONLY ONE YEAR
“The material sheds and is pulled into the ventilator air path,” Vincent Testa, a project mechanical engineer for Philips, said in an April 2018 email unsealed as part of consumer lawsuits overseen by a federal judge in Pittsburgh. “As you can imagine, this is not a good situation for our users,” Testa said. 

It wasn’t until June 2021 that Philips recalled 5.5 million Continuous Positive Airway Pressure (CPAP) machines and ventilators from the US market, after researchers linked the degrading foam to cancer and respiratory issues. The company has committed more than $800 million to the recall and repairs, but hasn’t disclosed estimates of litigation costs.

A company spokesperson, when asked about the unsealed emails, said that prior to 2021, Philips Respironics handled the complaints related to mechanical ventilators on a case-by-case basis. After Philips’ executive committee became aware of the issue and its significance in early 2021, the company issued a voluntary global recall notification to remediate the issue, the spokesperson said.

....

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. (Key terms are defined in 21 CFR 803.3.) Instructions are available for completing the required 3500A form.

Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. For more information please see the guidance for manufacturers on medical device reporting.





1) handled medical device complaints on a case-by-case basis? Not exactly the spirit of the FDA quality system and reporting requirements. Nobody thought that pressurized huffing of carcinogenic plastic particles into a patient's lungs could cause death or serious injury? Wow.

2) philips executive committee became aware of the issue and its significance in early 2021? three years after an engineer was looking into the matter? Wow. if you believe that, i have a bridge in frick park to sell to you.

Eat-popcorn

Now Mr Testa knows what the underside of a bus looks like. Someone in a pay-grade far above Mr Testa made the unconscionable soulless decision to delay the public disclosure and FDA reporting of these defective products until the new product was ready to be released.
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PHILIPS NEWS
"One year after a CPAP recall, some people are still left without a fix"
Millions of CPAPs and ventilators were recalled last year, and some people who use the devices still don't have an answer as to how to solve the problem.
FOX PA // June 16, 2022
https://www.fox43.com/article/news/local...dd674e1f48

Quote:PENNSYLVANIA, USA — It's been almost a year since millions of Philips CPAP machines were recalled. People who use the machines to sleep at night say it's been a nightmare to navigate and say they're still not getting a lot of answers.  

Since April of 2021, the FDA received more than 124 reports of deaths suspected to be related to the foam breakdown in the devices.  While the FDA investigates, people like Taylor have decided to take legal action against the company. He joined a class-action lawsuit.  "I'm going to take this all the way to the courts because my voice needs to be heard," he said.  There are reports of hundreds of lawsuits against the company and claims that Philips knew about the issue long before the recall.

FOX43 Finds out why it's taking so long to fix the problem and how many people may have died because of it.  Taylor says he has yet to be contacted by Phillips.  "We trusted in that company to give us a product (to keep us) from dying in our sleep that could kill us in 30 different ways or more," he said.

"Philips falls as UBS downgrades to SELL citing impact of product recall"
June 16, 2022

Quote:The analysts see a negative risk-reward set up ahead of the upcoming Sleep device testing data linked to the product recall. Citing their new work on a connected lawsuit, they also flag concerns over the potential for respiratory injury claims.  In addition, UBS rules out a resolution to the issue in 2023 and expects an FDA response to inspectional observations and the outcome of a DOJ subpoena to act as overhangs on shares.

... nearly ~40% YTD decline
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Oscar release 1.4.0 is live and the Dreamstation 2 is now supported by Oscar. http://www.apneaboard.com/forums/Thread-...s-released
Sleeprider
Apnea Board Moderator
www.ApneaBoard.com

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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(06-18-2022, 05:27 AM)Samultra Wrote: But Management goofed, the shareholders opined. Read below link using Google Translate:
https://www.iex.nl/Premium/Adviezen/7482...faald.aspx

Thanks for the pointer! It’s locked behind a paywall, as is the source article at fd.nl, but the 91-page Philips response to the FDA is here:

https://web.archive.org/web/202206190216...pdf%29.pdf
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