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

[Morseman]

I recently received a replacement DS1 through the recall.  I removed the modem, entered my old settings and tried some adjustments, but have not decided whether to continue using the new DS1 or to abandon it and purchase a ResMed unit to try for better results.  I also have not decided whether to return the old DS1.

Today I received an email from Philips prodding me to take action, stating in part "To maintain ongoing care, resupply of accessories and any warranty needs you may have, you must contact your Durable Medical Equipment Provider (DME) to inform them you have received your [replacement] device and they can place your serial number into their patient management system.  If you do not have a DME, contact your prescribing physician or insurance carrier for the names of DME providers in your area. " (emphasis in original)

I have NO desire for Philips to receive any of my personal health information or to be involved in my CPAP therapy, and would prefer to ignore this email and all future communications from Philips.  Does anyone see a problem with this?

[TimaaaaaaaahRocks]

"We are very pleased with these results, it is very important for patients to know that the use of the devices did not lead to a health risk", Philips Chief Executive Roy Jakobs told Reuters in a phone interview.

"It proves we have worked with a safe product, even though it might degrade."

Tests clear recalled Philips sleep apnoea machines of health risks - company | Reuters

What is "safe" about a non-fda compliant Class II medical device that degrades into a product that is harmful to patients? 

Not like resp had any meaningful, honest, or helpful advice to protect a patients' safety once they became aware of the problems; like, "discontinue use if you discover your pie hole is loaded with carcinogenic dust particulates", aka. a perfectly safe product undergoing a wee bit of nuisance degradation. 

You can't make this up. "It proves we have worked with a safe product, even though it might degrade." what the he11 does that mean? I think this proves one thing, and one thing only: it's time for Roy to pack his bags and collect his bonus on the way out the door. He just be like kicking the can down the road until the DOJ brings down the hammer - if the DOJ/FDA actually give a rats' behind about US law, patient safety, FDA rules/laws/regulations, and basic human decency. 

In April 2018, Vincent Testa, a project mechanical engineer shared via email, “the material sheds and is pulled into the ventilator air path.” He continued, “as you can imagine, this is not a good situation for our users.” - a defenselss position. 

[btreger]

Philips CEO said this, "It proves we have worked with a safe product, even though it might degrade." 

What he did not say or try to explain is this:

PE-PUR foams are formulated using isocyanates. 

Respiratory issues are the most common complication of isocyanate exposure. Health impacts range from shortness of breath and dry cough to asthma, bronchitis, and pneumonia.

Research has also linked isocyanate exposure to various forms of cancer. 

These are some of the potential side effects of ingesting degraded PE-PUR.

I think all this was explained at the very beginning of this Thread.

[cate1898]

Has anyone in Canada received either a new machine or had their machine fixed through the recall process? I have 2 machines, a system One 560 and a DreamStation Go, neither of which as been replaced or fixed. When I call Philips they say they have no information on Canadian recalls, only US. When I then contact the DME I am told they are still waiting on Philips. It's been just short of 2 years since I registered with the recall and have not been able to use either of my machines. Hoping someone has some useful information about this.

[btreger]

One 560 and a DreamStation Go, neither of which as been replaced or fixed.  

I can only speak about the Go machine. Philips has no plans as of today that address this machine, except to say they are still working on the details and to stand by for more information.

[ef651100]

Has anyone in Canada received either a new machine or had their machine fixed through the recall process?

I’m in BC. Wife and I both got our replacement DS1s (new with 0 hours, manufactured December 2022) last week through our DME. Our provider said that the replacements are only done through DMEs. Our DSgo systems are still waiting to be replaced and there is no timeline.

[btreger]

ABOUT LAWSUITS

Philips CPAP Lawsuit Filing Deadlines May Be Approaching in Some Claims

Lawyers are working to register and file Philips CPAP lawsuits, as the manufacturer may argue the June 14 anniversary of a massive recall triggered the start of the statute of limitations in certain states

With the two-year anniversary of a massive Philips DreamStation, CPAP, BiPAP, and mechanical ventilator recall approaching in the next few weeks, a spike in new claims filed and registered on a tolling agreement is expected, since the manufacturer may argue the recall announcement establishes a Philips CPAP lawsuit filing deadline for some claimants.

Philips CPAP Lawsuit Filing Deadlines May Be Approaching in Some Claims - AboutLawsuits.com

[btreger]

+MASS

DEVICE

How Philips’ significant respiratory devices recall unfolded 

Note: This article is mainly for newcomers to this Thread.
For those of us that have been here for the past two years, this might help refresh our memories of the events that we posted on.

There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline.

How Philips' significant respiratory devices recall unfolded (massdevice.com)

[SuperSleeper]

I'd just like to say thanks to those who are keeping us all updated with news and info about the recall.  It's certainly a complicated mess, for sure, so the info provided here definitely helps folks.

[btreger]

U.S. FOOD & DRUG

ADMINISTRATION


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

UPDATE - June 2, 2023: This safety communication was updated to provide information about medical device reports (MDRs) the FDA received from January 1, 2023, to March 31, 2023, that is reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021.

Note: This is the latest update from the FDA

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