Philips to Halt Sales of Sleep Apnea Machines
The company came to an agreement with the FDA to cease sales until the machines’ health hazards can be fully addressed.
Philips to Halt Sales of Sleep Apnea Machines

1/29/2024


Philips Respironics announced on Monday that it would suspend sales of all its breathing machines in the United States after coming to an agreement with the U.S. Food and Drug Administration (FDA) over ongoing issues with its sleep apnea devices.

“Patient safety and quality remain Philips’ highest priority across the company,” said Roy Jakobs, CEO of Royal Philips, in a press release. “Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused. We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”

Starting in 2021, the company issued a voluntary recall of some of its ventilators and CPAP machines, which millions of Americans have used to ease their breathing at night, after the FDA received reports that the foam used in the machines could disintegrate and be inhaled by users, along with resulting chemicals. According to the FDA, the machines used a polyester-based polyurethane foam to reduce sound and vibration. However, if subjected to hot and humid conditions, that foam could break down, posing a health hazard to users.

Some of the machines also caught fire as a result of overheating. Between Aug. 1 and Nov. 15, 2023, the FDA received over 270 reports of problems associated with the Philips DreamStation2 CPAP machine related to overheating.

“As a leading health technology company, our first priority at Philips is patient safety and quality,” wrote Steve Klink of the Philips Global Press Office in a press release. “We understand how important Philips Respironics’ sleep therapy devices and ventilators are to patients that use them and how they improve their lives every day and night.”

Under the guidelines of the settlement with the FDA, Philips said it must meet a list of standards in a long-term plan before it can return to selling breathing machines in the United States. In a press release, Philips said more details would be released in court. However, it did note it would continue to repair any existing devices and provide service so people may continue to use them. According to the company, Philips has remediated 99 percent of the actionable sleep device registrations.


The recall for Philips devices, including BiPAP and CPAP machines and ventilators, temporarily halted sales of new sleep therapy machines in the United States. More than 20 devices have been recalled due to a range of potential health problems reported as a result of using the products. Potential health problems include headache, skin, nose, or eye irritation, sinus infections, cough, asthma, nausea or vomiting, allergies, dizziness, or a feeling of pressure in the chest.
What Do I Do if I Have a Recalled Machine?
If you have a Philips CPAP, BiPAP, or other device that has been recalled, connect with your doctor to discuss your symptoms. The FDA also encourages individuals to report the problem through the MedWatch Voluntary Reporting Form.
The FDA also urges consumers to register their devices on the Philips website. Consumers must locate the serial number on their device to register it on the website.
If you do not find your device on the list of recalled models, consider contacting the medical equipment supplier that supplied your device. It will likely be able to tell you if your machine has been recalled.

The FDA warns consumers against stopping the use of their devices before consulting their physicians.

“For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use,” the FDA wrote in a press statement. “If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device.”

https://www.theepochtimes.com/...twjhRLVc3QbWrsBY4%3D

This message has been edited. Last edited by: downtownv,

Wow, this thing really blew up and bit them in the ass

I was issued a Philips DreamStation in Feb 2021 but never liked it or the mask and then when I heard about the recall in June of that year, I sent that machine back to the DME company and bought my own ResMed machine and mask and never looked back.

Not going to breathe off-gassing foam and particles and get lung cancer or something, no way no how.

Long story short: Glad I switched to ResMed as well.

Full story:
My original sleep apnea sleep test was from the first time I lived in Houston, and the result was for a BiPAP machine. Received new BiPAP every 5 years even when moving to Alaska and Canada.

When I moved back to Houston (different part 45ish minutes away from old location so different sleep doctor), my sleep quality had declined and downtownv helped me get the technician's manual to force my machine into "float." I mentioned that to my new sleep doctor and he recommended a new sleep study. Unfortunately, my old sleep study had been lost even though the doctor was with the same hospital network. The BS thing was that meant that I needed to re-establish having apnea in the first place. I barely slept the entire night due to sleeping without a CPAP for the first time in over a dozen years. By 5:30 AM, they barely had enough data to call it successful, and unfortunately the limited data they had said CPAP not BiPAP.

When the whole Phillips Respironics foam recall broke I was using their Dreamstation CPAP. I installed an inline filter on my air supply hose while I waited for the replacement. After about 6 months I received their free replacement, but I wasn't happy with my sleep quality. I talked the sleep doc into a another sleep study and this time it was a titrating CPAP study to get optimal settings. Low and behold my study came back that I needed a BiPAP. I might have used the phrase "I told you so"

I took the BiPAP opportunity to get away from Phillips Respironics and I have a ResMed.

I love units that are full auto. It constantly adjusts to compensate for your sleeping positions. they virtually eliminate Sleep Studies. Inside tip: the polysynographers (The sleep study Technician) boost sleep study pressures to the point of recording "No Hypopneas/No Snoring" The sooner they achieve that, the sooner they go home.
That's when the provider gets the script for overpressure, hence poor compliance.
The Auto's eliminate all that bullshit.

This is a great machine without the big name:

https://www.cpapsupplyusa.com/...to-cpap-machine.html

and this one:
https://compasshealthbrands.co...arch=resvent+ibreeze

drop me line if you are looking...

I have enjoyed my RESMED for 8 years now. I am currently on my second machine. I do however like the Phillips mask. I use the view. Maybe this will create more significant quality assurance.

I have ResMed too. Nice to know I have a good machine, but boy am I fighting this thing. I've progressed to the point where I feel like I don't have the Alien crab thing on my face when I first start it up. But if I wake up after three I have to take the damn thing off or I will never get back to sleep. The third night in I wasn't awake, and I must have just ripped the mask off. It was really fun finding those damn magnets the next day.

quote:

Originally posted by goose5:
I have ResMed too. Nice to know I have a good machine, but boy am I fighting this thing. I've progressed to the point where I feel like I don't have the Alien crab thing on my face when I first start it up. But if I wake up after three I have to take the damn thing off or I will never get back to sleep. The third night in I wasn't awake, and I must have just ripped the mask off. It was really fun finding those damn magnets the next day.

Sounds like you need to try some other masks and adjust your pressure and strap fit. How long have you had it? It only took me like 2-3 weeks to get fully used to it but I had to try 5 different masks until I found one that was comfortable and worked for me.

You shouldn’t be “fighting this thing”.

I'm two weeks in so far. I'm doing slightly better once I adjusted the ramp up to pressure to 30 minutes. I tried the full but minimal mask. It fits over the mouth, but under the nose. Wondering if I should go with the big one. I still wake up with a wicked case of dry mouth. Adjusted the humidifier up just one point, and woke up in the middle of the night gurgling. Had to unplug the hose and dump it out.

I started with a resmed 9.
It was replaced with a dreamstation after years of use.

Once the dreamstation was recalled I went back to my resmed 9 while my PCM wrote me a new script for a new resmed by name. It took over a year but I finally got a resmed airsense 11, which I am happy with.

Meanwhile, instead of repairing my dreamstation, Phillips sent me a brand new dreamstation II.

Now I am getting lawsuit settlement emails from Phillips. I think that Phillips never got out in front of this entire issue to begin with and, while trying to play catch-up, has just been falling further and further behind.

quote:

Originally posted by goose5:
I'm two weeks in so far. I'm doing slightly better once I adjusted the ramp up to pressure to 30 minutes. I tried the full but minimal mask. It fits over the mouth, but under the nose. Wondering if I should go with the big one. I still wake up with a wicked case of dry mouth. Adjusted the humidifier up just one point, and woke up in the middle of the night gurgling. Had to unplug the hose and dump it out.

A couple points:

1. I think those over the mouth/under the nose masks stink. I tried two of them and they just didn't work.

I love this one:

ResMed AirFit F20

2. The humidified air is condensing inside your hose because you probably have a heated hose and your room is colder than the hose is. I got a fabric hose cover and it eliminated this "rain out" issue. I have the heated hose set for 72 and the humidifier setting at 4 out of 8 and it's pretty good right there.

Heated hose cover:

JAKIA CPAP Hose Tube Cover Sleeve Wrap Insulator

The replacement Dream Station has been realy good for me, I will use it till it lays down than buy something else. I use the undernose pillows head gear.

Some of you are referring to a Nasal Pillow mask, they are minimistic, and used by anyone who is not a "Mouth Breather" The nasal pillows themselves are called Nairs each unit comes wit interchangeable sizes sm med and large so select a good seal is easy.

For a good pic:

https://shop.sleepdoctor.com/c...al-pillow-cpap-masks

I like the compass health product of these styles.

https://compasshealthbrands.co...L-Pillows-Included-/

This message has been edited. Last edited by: downtownv,

I received a repaired Philips machine I think last year. Is this saying that even the replacement ones are not safe to use or am I good to keep using mine?

quote:

Originally posted by cooger:
I received a repaired Philips machine I think last year. Is this saying that even the replacement ones are not safe to use or am I good to keep using mine?

Yes, that is the allegation that the replacement machines foam is doing exactly what the recall was all about.

Personally, I think Phillips is going to end up pulling out of the CPAP market altogether over this scandal, this just got too big for them and they did not get ahead of it quickly enough.

I have two CPAP machines, because I want to have a backup unit in case one fails. The one I used nightly was a Resmed Airsense 10, and I also had a Philips Dreamstation I that was used for travel.

Well, the Dreamstation got recalled, so I sent it in. Took them a year and a half to notify me they had a new one ready for me. I got the new Dreamstation version II, used it for a while, and it was terrible. I hated it. Put it away in a closet, and picked up another Resmed 10 on a smokin’ Black Friday sale. Now I’m happy again.

If I could get my old Dreamstation back, I would do it. That was a good CPAP. There was nothing wrong with it. The replacement they sent sucks.

I am done with Philips machines.

I have a Phillips Dreamstation that is at my other house. It is used occasionally, so I don't have to drag my other around. I never had any issues with it while using it daily. Phillips did send me another CPAP which I now use, but I don't recall its name.

What a lot of people leave out in the conversation is the use of cleaning machines for these CPAPs. IMHO, those are the leading cause of the breakdown of the foam insulation because most of them are using ozone. I never used one, and I never saw any black foam flakes on a filter I temporarily put on the hose end and let it run all day. Nor black flakes when I blew my nose in the morning. I just wipe my mask out with some hydrogen peroxide and do the same to the hose and water tank, then rinse with tap water and dry.

quote:

Originally posted by Glynn863:
I have a Phillips Dreamstation that is at my other house. It is used occasionally, so I don't have to drag my other around. I never had any issues with it while using it daily. Phillips did send me another CPAP which I now use, but I don't recall its name.

What a lot of people leave out in the conversation is the use of cleaning machines for these CPAPs. IMHO, those are the leading cause of the breakdown of the foam insulation because most of them are using ozone. I never used one, and I never saw any black foam flakes on a filter I temporarily put on the hose end and let it run all day. Nor black flakes when I blew my nose in the morning. I just wipe my mask out with some hydrogen peroxide and do the same to the hose and water tank, then rinse with tap water and dry.

It's not the breaking down or the flakes or particles that is the issue any longer. The problem is the newer and recall replacement machines are using a silicone foam now that apparently is off-gassing nasty stuff like formaldehyde and other chemicals right into your lungs at night.

I wouldn't touch a Phillips CPAP machine right now with a 40 foot pole.

This article is damning:

Philips Kept Complaints About Dangerous Breathing Machines Secret While Company Profits Soared

PASig thanks for the tips. I will look into it.

This just released in the medical trade journal"
PHILIPS NOW HAS ‘CLARITY’ TO REBUILD
‘WE ARE COMMITTED TO RESUMING THE SALE OF SLEEP THERAPY DEVICES IN THE US’
Vendors

Liz Beaulieu, Editor

Updated 10:48 AM CST, Wed January 31, 2024

Roy JakobsAMSTERDAM – With a consent decree nearly finalized and a more streamlined product portfolio, Philips believes its sleep and respiratory care business “bottomed out” at EUR 1 billion in revenues for 2023 and will "build back from there,” says CEO Roy Jakobs.

The company announced on Jan. 29 that it has agreed on the terms of a consent decree with the U.S. Food and Drug Administration related to Philips Respironics and its recall of certain sleep and respiratory care devices.

“We see that sleep and respiratory care bottomed, in terms of the EUR 1 billion of revenues, and with the clarity that we have now with the consent decree and the road map to get to compliance and to restore the business, actually we are able to build from there,” said Jakobs during a conference call to discuss the company’s fourth quarter and full-year financial results. “And that is also why we were happy to announce that actually we could now confirm that we remain on our plan, including any consent decree implication for 2023 to 2025.”

As a result of the consent decree, Philips recorded a provision of EUR 363 million in the fourth quarter of 2023 that relates to remediation activities, inventory write-downs and onerous contract provisions.

Until the relevant requirements of the multi-year consent decree are met, Respironics can’t sell new CPAP or BiPAP sleep therapy devices or other respiratory care devices in the U.S., but Jakobs pointed out that Philips has largely stopped selling CPAP devices in the U.S. already, as it has been focused on remediating devices affected by the recall, a process that is 99% complete. The company has, however, resumed selling devices outside of the U.S.

“We already stopped selling a lot in the U.S., right?” he said. “We continue with patient interfaces, which were the biggest part that was already in the forecast, including consumables and accessories. Furthermore, we are building back outside of the U.S. So, that’s something that comes actually on top of what we’re doing.”

Consumables and accessories, including masks, will continue to be a focus for Philips, following the company’s decision, announced four days prior to the announcement of the consent decree, that it would stop selling 19 sleep and respiratory products as soon as this month. While the DreamStation Go portable CPAP device was included on the list of discontinued products, other DreamStation devices were not.

“We are committed to resuming the sale of sleep therapy devices in the U.S., once the relevant requirements of the consent decree are met,” a spokesperson confirmed in an email to HME News.

Previously, Philips had established a three-year “recovery trajectory” for its sleep and respiratory care business that projected sales of EUR 600 million by 2025, but that was subject to the consent decree and other factors.

"We actually overdelivered (on) the first-year plan,” Jakobs said. “We said low single-digit growth where we did 7% growth. We said high single-digit EBITDA (and) we did 10.5% EBITDA, and we committed to EUR 700 million to EUR 900 million of cash (and) we did EUR 1.6 billion cash. That actually was excluding the consent decree. Now, we continue including the consent decree and we remain fully committed to the plan as we have. We remain very committed to the 3% to 5% growth for 2024 and that includes any impact of any pruning that we did in 2023.”

OK, after reading the article posted by PASig, I guess I don’t want my old Dreamstation back!