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In June 2021, Philips recalled millions of CPAP, BiPAP, and mechanical ventilators. Philips’ announcement explained that testing had shown the polyester-based polyurethane (PE-PUR) foam used to dampen the noise of the recalled devices presented health risks to the users. Users of the recalled Philips machines who developed cancer or other serious health issues are filing lawsuits.
Philips’ CPAP recall announcement explained that the PE-PUR foam could degrade into tiny particles that could be ingested or inhaled by the user, and that certain chemicals in the foam could also emit harmful gases. Philips claimed that using unapproved methods to clean the machines could make the foam degrade more quickly and that operating the machines in high heat and high humidity could also contribute to the problem.
Philips listed the known risks from exposure to the PE-PUR foam particulates as:
Philips reported the known risks of the chemical off-gassing as:
According to the FDA, this is a complete list of the recalled Philips Respironics models:
|CPAP and BiPAP Devices||Model Name and Number (All Serial Numbers)|
|Continuous Ventilator, Minimum Ventilatory Support, Facility Use||E30 (Emergency Use Authorization)|
|Continuous Ventilator, Non-life Supporting||DreamStation ASV, DreamStation ST – AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+|
|SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto|
|Ventilators||Model Name and Number (All Serial Numbers)|
|Continuous Ventilator||Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent|
Continuous Ventilator, Minimum Vent Support, Facility Use
|A-Series BiPAP Hybrid A30 (not marketed in the US), A-Series BiPAP V30 Auto|
|Noncontinuous Ventilator||A-Series BiPAP A40, A-Series BiPAP A30|
The FDA recommends that users of any recalled Philips CPAP machine talk to their doctors about treatment options. Depending on each patient’s particular situation, their medical providers may recommend that users:
If you are among the millions of consumers dealing with the Philips recall and its effects on your life and sleep, you probably have many questions. The FDA has created a web page with links to resources and answers to a fairly comprehensive list of Frequently Asked Questions about the Philips CPAP Recall. You can access it here: Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions
In September 2021, Philips began replacing the PE-PUR foam in the recalled machines with a silicone-based foam. However, in November 2021, the FDA released an update notifying the public that its testing found that the new silicone foam could still pose a health risk. The FDA had discovered that silicone-based foam used in a similar device sold outside the U.S. failed a safety test because it released of unacceptable levels of certain volatile organic compounds.
The FDA has not recommended that patients stop using the repaired machines containing silicone foam. But the FDA has asked Philips to hire an independent laboratory to perform additional testing on the silicone-based foam it is using. The FDA is still investigating and will likely provide updates when they have more information.
In August 2021 and November 2021, the FDA inspected the Philips Respironics manufacturing facility in Pennsylvania. As part of those inspections, they examined the company’s digital records, operations, and product testing. Investigators report finding evidence that Philips personnel had known of issues with the PE-PUR foam for years, and Philips executives knew about the problems for more than a year before issuing the recall.
In addition to emails and internal documents, the FDA inspectors cited at least 14 tests or assessments from as early as 2016 indicating Philips’ awareness of the foam’s problems and the potential for it to degenerate. FDA inspectors also cite a 2015 email from a Philips employee to their supplier implying that a customer had reported the foam degradation issues.
FDA investigators also observed that Philips had received hundreds of thousands of complaints about particles and other contaminants when the devices were used but failed to open a formal investigation. In response to the report, Philips said that the FDA may have overestimated the number of safety issues raised by customers in relation to the recall. Philips CEO Frans van Houten told reporters, “The complaints that were referenced by the FDA are the result of a very broad search. Therefore, the complaints did not necessarily relate specifically to the issue that led to the recall.” The company said it had acted on a total of about 1,250 complaints it deemed specific to the foam particulates. Philips also announced that the company and the FDA will go through the details together and release a full report when the investigation is complete.
The investigations into the Philips CPAP recall continue.
And while those investigations continue, many consumers who use CPAP machines remain somewhat confused, hungry for more information, and impatiently waiting for reliable and safe repairs or replacements. They also must watch their health for any signs of the carcinogenic and toxic effects of the foam used in the recalled devices.
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Dager, A. (2021, November 19). Patients say Philips medical machine recall didn’t come soon enough. Retrieved from https://wsbt.com/news/local/patients-say-phillips-medical-machine-recall-didnt-come-soon-enough
Hipwell, D. (2021, November 14). Philips Working with U.S. FDA After Mass Ventilator Recall. Retrieved from https://www.bloombergquint.com/onweb/royal-philips-working-with-u-s-fda-after-mass-ventilator-recall
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Kelly, S. (2021, November 15). FDA questions safety of Philips replacement foam for recalled devices. Retrieved from https://www.medtechdive.com/news/fda-philips-sleep-apnea-device-recall-resmed/610026/?utm_source=Sailthru&utm_medium=email&utm_campaign=Newsletter%20Weekly%20Roundup:%20MedTech%20Dive:%20Daily%20Dive%2011-20-2021&utm_term=MedTech%20Dive%20Weekender
Meijer, B. (2021, November 24). Philips questions number of complaints in FDA ventilator report. Retrieved from https://financialpost.com/pmn/business-pmn/philips-questions-number-of-complaints-in-fda-ventilator-report-2
Parker, L., and T. Jones. (2021, December 2). FDA Finds Maker of Recalled Sleep Aid Devices Knew Of Problems For Years, But Didn’t Act. Retrieved from https://www.nbcchicago.com/consumer/fda-finds-maker-of-recalled-sleep-aid-devices-knew-of-problems-for-years-but-didnt-act/2698459/
Schmitt, S. (2021, November 15). Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices https://medtech.pharmaintelligence.informa.com/MT144720/Damning-FDA483-Philips-Didnt-Investigate-222000-Complaints-Of-Possible-Degraded-Foam-In-Breathing-Devices
Staub-Zamperini, K. (2021, November 9). FDA-483 Observation Report. Retrieved from https://medtech.pharmaintelligence.informa.com/-/media/supporting-documents/medtech-insight/2021/11/philips-fda-483.pdf?rev=a78e6e1114044fa297146941dd43ba65&hash=DA609C004691B89223962C8AB1559932
U.S. Food and Drug Administration. (2021, June 30). Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks
U.S. Food and Drug Administration. (2021, November 12). Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions. Retrieved from https://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recall-frequently-asked-questions
U.S. Food and Drug Administration. (2021, July 15). Ventilators and Ventilator Accessories EUAs. Retrieved from https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/ventilators-and-ventilator-accessories-euas
You will never be charged a fee unless a recovery is made for you.