FDA Tells Consumers How to Get Their Philips CPAP Replacement Prioritized

Consumers can access an online patient portal to have their Philips CPAP Device's replacement prioritized, the FDA indicates

Amid continuing concerns about a lack of information and transparency following a massive sleep apnea machine recall issued last year, federal regulators have released updated guidelines for consumers describing how they can get their Philips CPAP replacement prioritized by the manufacturer.

The Philips Respironics recall was initially announced in June 2021, impacting an estimated 15 million DreamStation, CPAP, BiPAP and ventilator devices that were sold with a defective sound abatement foam, which has been found to deteriorate and release toxic particles directly into the machines’ air pathways.

Due to serious concerns about potential long-term side effects from breathing the CPAP foam, the FDA previously urged consumers to immediately stop using the machines for sleep apnea and other non-life sustaining treatments. However, replacement CPAP machines have been in short supply, and a Philips CPAP repair program is expected to take at least a year to complete.

Earlier this month, the FDA officials issued a scathing letter to the manufacturer, warning that the Philips CPAP recall notifications have been inadequate, leaving too many consumers and medical equipment manufacturers unaware of the health risks posed by continuing to use recalled sleep apnea machines with the toxic sound abatement foam.

This week, the agency updated the FDA’s Frequently Asked Questions page regarding the recall, adding new information about how consumers can be request a prioritized replacement of their Philips CPAP machine.

Philips CPAP Recall Lawsuit

Was your Philips CPAP machine recalled?

Millions of recalled Philips DreamStation, CPAP, BiPAP and ventilator machines may release toxic foam particles and chemicals into the air pathway.

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“If you want to be considered for prioritized replacement of your device, you may update your existing registration on the Philips Respironics’ online patient portal and provide additional information,” the FDA Philips Recall FAQ states. “You may visit the online patient portal and update your information even if you did not receive an email notification from Philips Respironics. If you do not provide the additional requested information, you will receive a replacement device based on when you registered.”

Questions About Safety of Repaired Philips CPAP Machines

Philips has indicated that it will attempt to repair recalled CPAP machines by removing the polyester-based polyurethane (PE-PUR) foam originally used, and replacing the sound abatement foam with a different material that it indicates is not prone to the same deterioration problems. However, the safety of these repaired Philips CPAP machines has not yet been independently certified, and the FDA has already expressed concerns about whether the replacement material may also release toxic chemicals and gasses.

Following an FDA inspection of the Philips manufacturing facility, the agency discovered that similar silicone foam used in a device marketed outside the U.S. failed a safety test for the release of “chemicals of concern”, which may also enter the machine’s air pathways, potentially causing similar health risks to the PE-PUR foam.

As a result, Philips has been required to retain an independent laboratory to perform additional testing to determine what safety risks the repaired CPAP machines with silicone foam may pose for consumers. However, the FDA is not yet recommending that patients who received a repaired device stop using their sleep apnea machine.

Philips CPAP Lawsuits

In the wake of the recall, tens of thousands of individuals nationwide are now pursuing a Philips CPAP lawsuit against the makers of the sleep apnea machines, already alleging that they developed various respiratory injuries and cancers that may have been caused by breathing the chemicals and gases released as the foam breaks down.

Given common questions of fact and law raised in product liability and class action lawsuits over recalled sleep apnea machines filed throughout the federal court system, the litigation has been centralized before Senior U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania for coordinated discovery and pretrial proceedings, as part of a multidistrict litigation (MDL).

There are also now a number of SoClean lawsuits being filed against the manufacturer of an ozone cleaning device commonly used to sanitize the Philips CPAP machines, alleging that the process accelerates the breakdown of the PE-PUR foam. However, SoClean maintains that ultimate responsibility for the CPAP recall rests with Philips, for selling a defectively designed machine and ignoring evidence that the foam was breaking down.

5 Comments

  • TimFebruary 20, 2023 at 6:55 pm

    It is now going on 2 solid years since this RECALL was issued and Phillips Respironics is playing with peoples health!!! I know it is bu far PAST DUE for them to REPLACE the machines that are in THEIR RECALL and do it NOW!!! I am NOT going to take a NEW sleep study due to Phillips inability to build a quality, trouble free machine. And how do they insult me offering me $50 for my machine?????[Show More]It is now going on 2 solid years since this RECALL was issued and Phillips Respironics is playing with peoples health!!! I know it is bu far PAST DUE for them to REPLACE the machines that are in THEIR RECALL and do it NOW!!! I am NOT going to take a NEW sleep study due to Phillips inability to build a quality, trouble free machine. And how do they insult me offering me $50 for my machine??????? NO. The replacement needs to happen NOW ! ! !

  • annFebruary 5, 2023 at 9:07 pm

    As far as I can tell Phillips is giving me the big run around!

  • PeggyFebruary 2, 2023 at 11:41 pm

    I have my prescription. How do I get it to you? I tried to email it but the email says no reply. I have been extremely I’ll with respiratory problems. I sure could haused it the last 6 weeks!

  • WilliamDecember 4, 2022 at 3:12 am

    I have never received a notification that my machine was defective. I went to Pulmanary associates where I bought my 1st machine and they tell me a new machine will cost $1200.00 out of my pocket because I no longer have insurance and Phillips Respironics is not responsible for any thing more than 5 years old. It doesn’t seem right that they are not responsible and get to make even more money off[Show More]I have never received a notification that my machine was defective. I went to Pulmanary associates where I bought my 1st machine and they tell me a new machine will cost $1200.00 out of my pocket because I no longer have insurance and Phillips Respironics is not responsible for any thing more than 5 years old. It doesn’t seem right that they are not responsible and get to make even more money off of there customers that are in need of there cpaps.

  • dennisSeptember 27, 2022 at 2:00 pm

    I have been told for over a year that my replacement unit would be to me by sept, 2022. Now I call and I am told that it is not been matched to my DME. I have congestive heart failure, stage 4 liver cirrhosis and now I am experiencing severe throat issues. I was offered a rental unit at 50 some dollars a month, If i would have done that, I would have paid for a whole new unit by now. I have c[Show More]I have been told for over a year that my replacement unit would be to me by sept, 2022. Now I call and I am told that it is not been matched to my DME. I have congestive heart failure, stage 4 liver cirrhosis and now I am experiencing severe throat issues. I was offered a rental unit at 50 some dollars a month, If i would have done that, I would have paid for a whole new unit by now. I have called these people probably over a dozen times and get a different answer everytime. The best one I was told was, Your unit is old and you should get a new one thru your insurance company. My original was paid in full, Insurance does not pay for these in full anymore. So much for the urgency to get these to the people who are in danger!!

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