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

[OpalRose]

dosco,
Have you looked at EBay?

Do a search for "Phillips DreamStation Foam Replacement Kit"

[Moriarty]

Try eBay perhaps…
https://www.ebay.com/itm/334416230040

[WakeUpTime]

"For sleep apnea patients with recalled CPAP machines, restless nights"
The Washington Post | July 28, 2022
https://www.washingtonpost.com/health/20...eep-apnea/

Jenny Shields was terrified when she would awaken coughing and spitting up phlegm seeded with black specks. “I couldn’t figure out what it was,” she said... Her doctor was mystified. Eventually, Shields found out a machine she uses to control a serious medical condition had been recalled because it could spew particles and gases into the device’s air pathway.

But as the voluntary recall enters its second year, the pace is excruciatingly slow. Philips says it has repaired or replaced only about half of the 2.8 million affected devices in the United States and 3 million of the 5.5 million machines around the world. The recall, originally scheduled to be completed this fall, will stretch into next year.

That leaves millions of patients in the lurch, many of whom are railing against Philips on social media and flooding the inboxes of FDA officials with complaints. “This is dangerous, you stop breathing, that’s why you are using it,” said Christine Hinckley, who lives in Prospect, Conn. “Someone needs to do something. Months go by and you hear nothing. Nothing.”

The FDA, usually tight-lipped about companies, has taken an aggressive stance with Philips, accusing the company of being too slow in notifying consumers about machines that the agency suggests were defective from the outset... The FDA also said there was evidence some company officials knew about problems as early as 2015 — six years before the FDA was notified.

After Shields heard about the CPAP recall, the Wilmington, Del., resident stopped using the Philips machine, and the black spots in her phlegm disappeared.  Shields said she was infuriated by a lack of information from Philips. “If Honda … can track me down and tell me to replace my air bags, why can’t Philips find me?” she said.

The FDA has expressed skepticism about Philips’s test results, saying in May that certain data were “not persuasive” and rejecting the company’s argument that use of unapproved ozone cleaners is a main culprit. The agency has suggested the machines were not made properly in the first place. The FDA told The Post that many tests “are still outstanding” and that recommendations by the agency and Philips about the devices have not changed.

Tom Wilson, a retired corporate executive, began using a Philips CPAP device in spring 2018 after being diagnosed with sleep apnea. By that fall, he started coughing excessively and vomiting. In June 2021, when the recall was announced, he stopped using his machine and bought one from ResMed, another big manufacturer. Wilson now runs a Facebook support group on the Philips recall with more than 4,000 members who post about their frustration.

At Wilson’s suggestion, several members have emailed Jeffrey Shuren, director of the FDA’s device center, to complain about the difficulty of getting replacement machines. Wilson said Shuren asked him for permission to forward some of the complaints to Royal Philips’s CEO.

[WakeUpTime]

[Health Canada] "Advisory Update on Philips Respironics Recall"
Canada NewsWire | July 27, 2022
https://finance.yahoo.com/news/advisory-...00133.html

Health Canada is providing an update on the progress of Philips Respironics' (Philips) recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators in Canada.  Philips has confirmed that it is repairing or replacing all devices affected by this recall, irrespective of the age of the device. Philips may replace devices with the same model, or a different Philips device that will meet the needs of the patient. Philips has advised Health Canada that it expects to complete its repair and replacement program in Canada by the end of 2023.

To date, Health Canada has authorized licence amendments for all DreamStation CPAP and Bi-level Therapy devices (other than DreamStation Go devices).  Philips has yet to submit packages to Health Canada for A-Series, DreamStation Go, OmniLab, and Trilogy devices.  Once a licence amendment is authorized by Health Canada, Philips has indicated that it may take up to a year for that product to be repaired or replaced.

[Australia Dept of Health]  "Philips recall action for CPAP, Bi-Level PAP devices"
Mid 2022 progress update |  8 July 2022
https://www.tga.gov.au/alert/philips-rec...entilators

Over 60% of the affected devices registered with Philips in Australia have now been corrected under the repair/replacement program.  There have been some delays to devices being corrected. This is due to a variety of reasons, some of which are beyond Philips' control. We are working with Philips to minimise these delays where possible.  Despite the delays, Australian patients are receiving their corrected devices ahead of many global markets.

Some patients have received replacement BiPAP devices with settings (patient scripts) that have been incorrectly installed by Philips.  Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. 

The TGA [Australia Therapeutic Goods Admin] has taken regulatory action and fined Philips for the delay in providing important information.  Philips are now required to meet weekly with the TGA to ensure that progress with the remediation plan remains on track and any further delays to the repair/replacement program are identified as soon as possible.

[StratCat48]

WakeUpTime.......

In your previous post, were Shields and Wilson users of a SoClean device or similar? Without that knowledge we can't know if their problems were possibly self inflicted.

[dosco]

StratCat48:
Not sure if you noticed it was an article from the Washington Post.

Any info about ozonation was not included (and frankly the lack of that detail is not surprising, IMO).

Best-
Dave

[StratCat48]

dosco.....

"Not sure if you noticed it was an article from the Washington Post.


Any info about ozonation was not included (and frankly the lack of that detail is not surprising, IMO).

Best-
Dave"

Yes, I was fully aware of the source of the article. Without knowing if an ozone device had been used by those respective people, the lack of information could essentially lead the readers to an incorrect conclusion that any and all Philips devices mentioned in the article could have the same or similar health consequences which is not true. I'm sure the WP writer had fully intended to report completely and accurately, but the omission of relevant details damages the credibility of the article to informed readers. The WP writer can only work with information they have available. The devil is in the details     .

[dosco]

StratCat48:
Completely agree. Well said!

Best-
Dave

[btreger]

AboutLawsuits

Science “Show and Tell” For Philips CPAP Lawsuits and SoClean Lawsuits Scheduled For Sept. 1

The court will hear educational presentations about complex scientific issues that will come up in thousands of Philips CPAP lawsuits and SoClean lawsuits

It is now known that the toxic foam breaks down, releasing particles and gasses directly into the machine’s air pathways, which has been linked to reports of cancer, lung damage,  and other injuries in thousands of lawsuits filed by former users.

Philips indicated that CPAP cleaning devices like SoClean, which use high levels of ozone gas to sanitize the machines, could increase the rate of foam degradation.

As part of the coordinated pretrial proceedings before Judge Conti in the two separate MDLs, SoClean lawyers and Philips CPAP lawyers will conduct coordinated discovery into issues raised in the claims, as well as overlapping issues about the causes and effects of the foam breaking down, which will likely involve many of the same witnesses and evidence. It is then expected that Judge Conti will schedule a series of early “bellwether” trials to help the parties gauge how juries will respond to certain evidence and testimony that will be repeated throughout the claims.


 

Science "Show and Tell" For Philips CPAP Lawsuits and SoClean Lawsuits Scheduled For Sept. 1 - AboutLawsuits.com

[btreger]

LAWSUIT: PHILIPS KNEW CPAP SLEEP MACHINES LINK TO CANCER


Santa Clara, CA. Philips has been slammed with another Dreamstation lawsuit, alleging the company knew its sleep machines could cause cancers and other injuries years before the worldwide recall.

Lawsuit: Philips Knew CPAP Sleep Machines Link to CancerMario Olivares filed the lawsuit in mid-June in the U.S. District Court for the Western District of Pennsylvania, claiming that Philips knew for years that its sleep apnea machines were defective. The lawsuit (Olivares v. Koninklijke Philips N.V. et al, case number 2:22-cv-00877) contends that the company knew its sound abatement foam inside the devices would carry serious health risks for users. Olivares was diagnosed with urinary tract infections, bladder cancer, and kidney cancer, resulting in the removal of a kidney, and he continues to undergo surgeries for bladder cancer.

THE 510(K) PROCESS AND PHILIPS

In 2012, at the request of the FDA, The National Institute of Health conducted a thorough review of the 510(k) process, concluding that this “is not intended to evaluate the safety and effectiveness of medical devices with some exceptions. The 510(k) process cannot be transformed into a pre-market evaluation of safety and effectiveness so long as the standard for clearance is substantial equivalence to any previously cleared device.”

WHEN PHILIPS KNEW

Philips monitored message boards, such as apneaboard.com and reddit.com, and social media networks, such as Facebook, and therefore the lawsuit contends that it noticed complaints on social media, such as the following:

2018:  The user “trickyneedsleep” reported on apneaboard.com that the filters of his DreamStation Auto turned black within three
days of use.

2019: The user “WSHenry” reported on apneaboard.com in a thread entitled “DreamStation Filter Contamination” that “both the pollen and ultra-fine filters in my machine were clogged with black (Carbon?) particles.” The user further noted that the “water chamber was completely dry. There were odd odors noted, and the water chamber was undamaged.” He explained that he had recently cleaned the filters and that “[t]here was only a small amount of dust on the furniture, and the machine and tubing is clean. I do not burn candles nearby, and the furnace is off. I do have the window slightly opened, as is the case nearly year-round.” The user asked: “Is it possible the contamination is from the blower?”

2019: The user “Skogcat1” reported on apneaboard.com in a thread entitled “Black sticky dust in CPAP machine” that, when using the REMStar Auto, there were “sticky black dust particles” in the humidifier chamber.

Lawsuit: Philips Knew CPAP Sleep Machines Link to Cancer (lawyersandsettlements.com)