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

[Captain Howdy]

Received my replacement Philips Dreamstation last night here in West Oz. No drama. Easy free solution for posting the old one back too.

[WakeUpTime]

"Sleep apnea device recall drags on, stoking frustration"
https://journalrecord.com/2022/10/25/sle...ustration/

"Philips faces more legal action for sleep apnea device recall"
https://www.econotimes.com/Philips-faces...ll-1644336

"Recall Of Philips CPAP Device Causing Worldwide Shortage Of Devices"
https://www.newsy.com/stories/recall-of-...ea-device/

U.S. officials are weighing unprecedented legal action to speed a replacement effort that is set to drag into next year.

“For them to wait until October to tell me that my machine is too old, when they’ve known exactly what device I have since the day I registered – that’s frustrating,” Reed said. “It’s disappointing that a provider of life-saving equipment treats people like this.”

The company says it has replaced or repaired about 69% of recalled devices globally and aims to ship 90% of those requested by year’s end. On average, the company produces about 1 million sleep devices annually.

In a May 2018 email, foam supplier William T. Burnett wrote to Philips in an email:

                          “We would not recommend use of polyester foam
                            in such an environment.  It will eventually
                                      decompose to a sticky powder,”

according to an affidavit filed as part of a lawsuit over the foam.

“The FDA shares the frustrations expressed by patients who are awaiting a resolution for this recall,” the agency said in a statement. Philips still hasn’t provided “all information we requested to evaluate the risks from the chemicals released from the foam.”

Philips disclosed earlier this year that it received a Department of Justice subpoena over the recall. The agency hasn’t publicly commented on the matter, per federal rules.  But an FDA inspection of Philips’ Pennsylvania offices uncovered a spate of red flags last fall, including emails suggesting the company was warned of the problem six years before the recall. In an October 2015 email, one customer appeared to warn Philips that the polyester polyurethane foam could degrade, according to FDA.

In May, the FDA put Philips on notice that it was considering a second order that would force the company to improve and accelerate its repair-and-replace program.

Jeffrey Reed, of Marysville, Ohio, had been using his Philips machine for about a year when he began seeing black specks in the tubing and mask. His equipment supplier said the debris was caused by improper cleaning, so he continued using it.

Over the next seven years, Reed says he experienced persistent sinus infections, including two bouts of pneumonia, that didn’t resolve with antibiotics. After hearing about the recall, he suspected the foam particles might be playing a role.  “Once I got off their machine, all of that cleared right up,” said Reed, 62, who obtained a competitor’s device after several months. Like other users, Reed can’t definitively prove his problems were caused by Philips’ device.

More than 340 personal injury lawsuits against Philips have been consolidated in a Pennsylvania federal court and thousands more are expected in coming months. Reed isn’t part of the litigation.

[btreger]

New Orleans Injury Law News

      legal examiner

Philips To Pay Pay Millions to Resolve False Claims Act Allegations

Philips will pay millions of dollars to resolve allegations that the company paid kickbacks to suppliers in exchange for them filing claims with the federal healthcare programs Medicare, Medicaid, and Tricare for Philips devices. Philips RS North America, a subsidiary of Philips formerly known as Respironics, will pay more than $24 million to the government. The settlement happened because a whistleblower came forward to report fraud. The manufacturer is also accused of giving suppliers access to prescribing data for free to help them market devices to physicians. 

According to the Justice Department, Philips provided illegal incentives to durable medical equipment (DME) suppliers. In return, the suppliers submitted claims for CPAP and BiPAP machines, ventilators, oxygen concentrators, and other medical devices. This behavior violates the Anti-Kickback Statute, a law that forbids paying remuneration for patient referrals if federal healthcare programs are involved. Both those who pay kickbacks and those who receive them can be held liable, and violators may face fines and jail time.

Philips To Pay Pay Millions to Resolve False Claims Act Allegations (legalexaminer.com)

[btreger]

RTL


LUXEMBOURG - FAULTY RESPIRATORS

More than 1,000 Luxembourgers affected by Phillips product recall
Author: Fanny Kinsch - adapted for RTL Today|Update: 14.11.2022 08:32

Even though the recall was done on June 14, 2021, it seems that some customers were not warned about the issue with these devices, which are usually used for sleep apnea. At the end of October this year, patients' representatives, therefore, drew attention to the product recall. As a result, one person came forward for using one of the affected respirators but not have been informed about the defect.

Spokesperson Georges Clees elaborated: "We realized that nothing had yet happened in Luxembourg, nobody was made aware of the defect. We then immediately announced the issue on Facebook and on our website to inform people. We also sent emails to the Ministry of Health and the Health Directorate to monitor the case's progress."

Hospital Federation FHL was only made aware of the product recall last week, says secretary general Sylvain Vitali: "According to the information given to us by the Health Directorate, there are more than 1,000 patients here in the country that use such a device. In cooperation with [National Health Fund] CNS, we are now contacting all of them to repair or replace the devices."

Two out of four Luxembourgish hospitals have been affected by the recall. According to initial statements from the Ministry of Health, 873 devices were involved at the Centre Hospitalier du Nord (CHdN), but it now turns out that the Robert Schuman Hospitals also received faulty devices.

RTL Today - Faulty respirators: More than 1,000 Luxembourgers affected by Phillips product recall

[btreger]

The New York Times


Frustrations Grow Over Company’s Response to Breathing Device Recalls

Lawsuits claim the company, Philips Respironics, knew of problems with its CPAP and other machines long before notifying customers of potential health risks.

By 2015, Philips Respironics knew its breathing devices had a problem: Foam inside the CPAP machines,  which help people with sleep apnea breathe at night, was breaking off into black flecks and blowing into the mouths and noses of users.

The company did nothing at the time. Years went by as complaints mounted, and the company made cursory efforts to examine the problem, according to an investigation conducted later by the Food and Drug Administration.

As the recall unfolded, doctors said they were ill-equipped to balance the risks of the toxic chemicals against those of letting interrupted breathing go untreated, which can heighten the risk of cognitive decline, heart problems, and death. Device users have despaired over the difficulty of getting a replacement device or have bristled at deliveries of reconditioned models, which the company said account for about half of the replacements.

The FDA review of company records showed that by 2015, the company had information from complaints, test reports, and suppliers that the foam in the devices was degrading. Yet it “failed to adequately evaluate” the information or mitigate the problem, the F.D.A. noted.

In 2016, emails and test reports showed Philips learned that the foam could break down in as little as a year, F.D.A. records say. By 2018, a company engineer noted that the foam breakdown in a Philips ventilator was “not a good situation for” device users according to an email submitted in a lawsuit against Philips.

Frustrations Grow Over Philips’s Response to CPAP Device Recalls - The New York Times (nytimes.com)

[Brentjackson]

Great! Thanks for your patience with me as I work through all this!

[btreger]

Australian Government

Department of Health and Aged Care

Philips recall action for CPAP, Bi-Level PAP devices, and mechanical ventilators - Update on Trilogy 100 Ventilators

Product Defect Alert - New problems with corrected ventilators

Philips Respironics (the manufacturer) has detected two problems with the corrected Trilogy 100 ventilators.

What are the problems with the corrected Trilogy 100 ventilators?

Problem 1 - Foam blocking the airway

Problem 2 - Debris in the airway

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators - Update on Trilogy 100 Ventilators | Therapeutic Goods Administration (TGA)

[WakeUpTime]

Philips recall action for CPAP, Bi-Level PAP devices, and mechanical ventilators - Update on Trilogy 100 Ventilators
Product Defect Alert - New problems with corrected ventilators
Problem 2 - Debris in the airway

Although the latest FDA alert issued (as a result of Australia's latest Philips defect alert) on the updated foam was for the Trilogy ventilators, isn't this the same updated foam used in the 4 million (so far) replacement devices issued?  

[November 18, 2022  https://www.medtechdive.com/news/philips...DA/636914/] 

Regulatory officials also flagged the discovery of trace amounts of particulate matter in the air pathway of some reworked ventilators. Preliminary results from an analysis by a third-party laboratory show some samples contain PE-PUR and environmental debris. Other samples only contain environmental debris.

The FDA notice features no specific information about the response to the new potential issues, stating only that questions should be directed to Philips. Australia’s Therapeutic Goods Administration, which issued a product defect alert about the issues almost one week before the FDA, provided more details. It advises users who experience a ventilator alarm that doesn’t resolve to switch to their other device. 

Philips is arranging delivery of an inline bacterial filter to Australian customers to minimize the risk posed by the particulate matter. The filter is designed to minimize exposure while Philips works on a permanent fix.

Also...

"Family says recalled breathing device caused Utah woman’s death"
https://www.sltrib.com/news/nation-world...breathing/

By 2015, Philips Respironics knew its breathing devices had a problem: Foam inside the CPAP machines, which help people with sleep apnea breathe at night, was breaking off into black flecks and blowing into the mouths and noses of users.  The company did nothing at the time. Years went by as complaints mounted, and the company made cursory efforts to examine the problem, according to an investigation conducted later by the Food and Drug Administration.

But it was not until April of last year, the company has claimed, that it realized the flaking foam contained potentially cancer-causing particles, setting off the largest and most disruptive medical device recall in more than a decade.

Nearly a year and a half after the recall, which involved more than 5 million devices worldwide, millions of American have endured a long wait for a device. Many have been forced to find alternative methods to ensure they can breathe at night without becoming deprived of oxygen or risking a heart attack. Others have been outraged by unexpected illness, suspicious that a device meant to help them actually caused harm.

The Justice Department is now negotiating the terms of a consent decree with Philips, underscoring the deep concern about what the company knew — or should have known — before millions of people received devices that many believe caused devastating illnesses. A decree would most likely require the company to document the steps it would take to prevent such a failure in the future.

"NBC 5 Responds to Consumer CPAP Machine Concern"
November 18, 2022  |  NBC Dallas
https://www.nbcdfw.com/news/nbc-5-respon...n/3129467/

Philips offered two options: return the old machine for a $50 check or request a replacement device with a current prescription.
“It was a year in August that I got the paperwork when I registered it. If that's the case, then why didn't they say that back then?” Wright asked.

Philips claims to have issued 4 million replacement devices, although they still can't seem to find a way to replace my recalled DreamStation APAP (purchased second-hand) and System One BiPAP (purchased new).  They say I'm on the list and they regret the 18+ month (so far) delay.  I was temporarily off the list while they awaited my response to their $25 offer for my Philips System One BiPAP.  Perhaps I'm at the bottom of the list yet again.

[btreger]

Regard >above<

WakeUpTime Wrote:

"Although the latest FDA alert issued (as a result of Australia's latest Philips defect alert) on the updated foam was for the Trilogy ventilators, isn't this the same updated foam used in the 4 million (so far) replacement devices issued?" 

The answer is yes.
This was the FDA's response in their Update - November 17, 2022. No new updates have been issued to my knowledge on the silicone foam.

Silicone-based Foam


During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replacement program.


Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replacement program discontinue the use of their product. The FDA has reached this determination based on an overall benefit-risk assessment. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. Patients who have additional concerns should talk to their healthcare provider about the plan for their care and treatment.

Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication | FDA

[KSMatthew]

My replacement showed up on my porch yesterday. DreamStation 2. I bought a ResMed Airsense when the DreamStation recall began, so now I have my AirSense and a new DS2.