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Phillips Recalls CPAP Devices

danieltx

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Looks like the only one not being recalled is the Dreamstation 2. I have an original Dreamstation and will continue using it until I find a better device, I can't get quality sleep without it.

https://www.yahoo.com/finance/news/philips-recalls-3-4-million-055353068.html

AMSTERDAM (Reuters) -Dutch medical equipment company Philips has recalled some breathing devices and ventilators because of a foam part that might degrade and become toxic, potentially causing cancer, it said on Monday.

Foam used to dampen the machines' sound can degrade and emit small particles that irritate airways, the group said as it announced the recall. Gases released by the degrading foam may also be toxic or carry cancer risks.

Philips Chief Executive Frans van Houten said the company was one of the largest makers of sleep apnea machines and ventilators. Between 3 million and 4 million would be targeted in the recall, he said.


The group took a 250 million euro ($303 million) charge for the issue after announcing an identical provision in its first quarter-earnings report in April, bringing the total cost of the problem to 500 million euros to date.

Shares in the group were down 4.2% to 44.42 euros by 0850 GMT in Amsterdam.

"We're going to put all our capacity to focus entirely on replacing and repairing these units," Van Houten said in a call, a process he said would likely take a year.

That "has a consequence that we will not be able to serve new customers, so there's going to be a shortage in the field".

Company spokesman Steve Klink said about 80% of the affected devices were machines used to help people with sleep apnea, known as Continuous Positive Airway Pressure (CPAP) machines. Users of those machines were advised to halt usage. Around two-thirds of Philips CPAP machine sales are in the United States.

The other 20% of affected devices were ventilators. Doctors and patients using life-sustaining ventilators should first consider whether the potential danger from the foam outweighs other risks, the company said.

"Philips has received reports of possible patient impact due to foam degradation," the company said in a statement. "To date, there have been no reports of death as a result of these issues."

Spokesman Klink said Philips had received some complaints about the devices, representing 0.03% of those sold in 2020.

The company said the matter would cause "revenue headwinds" in the division making the devices but that would be compensated by strength in other businesses.

It left its full-year financial guidance of "low-to-mid-single-digit" comparable sales growth unchanged.

Philips said it was working with health authorities on a safe replacement for the foam, but that it must first clear testing and regulatory hurdles.

In April, Philips said first-quarter core earnings surged 74% to 362 million euros compared with the same period a year earlier, on a 9% rise in comparable sales./
https://www.usa.philips.com/healthc...8.1773809655.1623694403-1849336464.1623694403

The link above has a place for end users to make a claim but they haven't added all that info yet.
 
I got the recall notice from my Dr. about this. Called, left a message and no return call. Must not be too pressing or else they are overwhelmed because they prescribe mostly these machines. I'll try again tomorrow I suppose.

Daniel- if you are concerned about this issue and do not have good medical for a replacement, shop around on Craigslist and eBay. You can usually find them there.
 
I got the recall notice from my Dr. about this. Called, left a message and no return call. Must not be too pressing or else they are overwhelmed because they prescribe mostly these machines. I'll try again tomorrow I suppose.

Daniel- if you are concerned about this issue and do not have good medical for a replacement, shop around on Craigslist and eBay. You can usually find them there.
I got mine off Craigslist. I've actually got a Dreamstation 2 on the way right now.
 
I had a few customers tell me that they saw black particles in the water chamber area of their Dreamstations.

What some have done is plug in a bacterial filter. That should stop the particles.

Apparently there is a foam part in the Dreamstation that can break up and get in to the air supply and inhaled in to the lungs.
 

If you put in your S/N, it will tell you if yours is affected. Mine is, says they will send new one, but of course will take ages.
I entered mine and it's affected. However, I'm in Canada and this is what I got upon submitting

We regret that it may take some time to replace your device. The repair process for existing devices requires regulatory approval in your country, which we are working toward obtaining as quickly as possible.

So could be years "for them to approve replacement" aka let's drag this out so we don't get hit with all the costs immediately
 
Yep, mine is affected.

Time to look around and find a new one
 
I highly recommend the Dreamstation 2 for those needing a new one. It's half the size of the original Dreamstation, quieter, menus are all touchscreen, and a full water reservoir lasts 2+ nights.

When you get a new one make sure to adjust ALL the settings. My Dreamstation 2 worked well for 2 weeks but then I started feeling like I wasn't getting enough airflow through it and my sleep started suffering. Turns out it was set to continuous CPAP mode instead of APAP mode so the airflow wasn't automatically adjusting, which is crucial at any point but particularly right now as my weight's jumping up.
 
Update here - Philips has now agreed to stop selling CPAPs in the US. If you didn't take advantage of their replacement offer or buy a new one yourself I highly recommend you do as they're still unsure of the long-term health risks from impacted machines.

https://finance.yahoo.com/news/maker-millions-recalled-sleep-apnea-190454561.html

The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the manufacturer nearly $400 million.

Device maker Philips has recalled more than 5 million pressurized breathing machines due to risks that their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep.

The company first announced the problem in mid-2021, but efforts to repair or replace the machines have dragged on for years, frustrating patients in the U.S. and other countries.

The Dutch manufacturing giant said it has agreed to a consent decree with the Food and Drug Administration and the Department of Justice. The deal has not yet been finalized and will have to be approved by a U.S. judge. Philips executives disclosed the tentative agreement during a quarterly earnings update.

Under the agreement's terms, Philips would continue servicing previously sold machines in the U.S., but couldn't sell new ones until it meets corrective actions laid out by the FDA. Company executives said they have set aside $393 million for operational changes and upgrades needed to comply.

The company promised it would put "safety and quality at the center of everything we do with a greater level of accountability,” Philips CEO Roy Jakobs told analysts and investors.

The FDA's website warns patients that the risks of ingesting the sound-dampening foam could include headache, asthma, allergic reactions and more serious problems. In November, the agency issued a new warning that the machines can overheat, in rare cases causing fires.

The agency said it cannot comment on Philips' announcement until a final agreement is “signed and filed with the court.”

In 2022, the FDA took the rare step of ordering Philips to step up its outreach to customers about the recall including “clearer information about the health risks of its products.” At the time, the agency estimated only about half the people in the U.S. with affected machines knew they had been recalled.

Customers trying to obtain refunds or new or refurbished devices from the company have reported months of delays.

Most of the recalled devices are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep passageways open during sleep. The company has also recalled certain lines of ventilators and other breathing devices.

Untreated sleep apnea can cause people to stop breathing hundreds of times per night, leading to dangerous drowsiness and increased heart attack risk. The problem is more common in men than women, with estimates ranging from 10% to 30% of adults affected.

On Monday, Philips again pointed to company-commissioned studies suggesting that inhaling foam from its machines is “unlikely to result in appreciable harm” to patients. The company has discontinued several of the recalled models.

The latest announcement does not resolve 675 personal injury lawsuits filed against the company over the devices. Those cases have been consolidated in a federal court in Pennsylvania.

Philips faces similar legal challenges in Canada, Australia, Israel and Chile, according to the company's update.
 

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