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# FDA Updates Philips MDRs; 82 Deaths in 2 Months
- URL: https://www.fdaweb.com/fda-updates-philips-mdrs-82-deaths-in-2-months/
- Published: 2023-02-09T12:00:00.000Z
- Updated: 2026-09-14T18:15:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153743

FDA has [updated](https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due?utm%5Fmedium=email&utm%5Fsource=govdelivery#mdr) an ongoing safety communication on Philips Respironics ventilators, BiPAP machines, and CPAP machines to provide updated information about [medical device reports (MDRs)](https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due?utm%5Fmedium=email&utm%5Fsource=govdelivery#mdr) that the agency received from 11/1/2022 to 12/31/2022\. The devices have been associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in them.

The notice says that during the latest reporting period, Philips submitted over 8,000 MDRs that included 82 deaths. It says the agency’s in-depth review and analysis of the new MDRs will include examining the possible reasons for the increased number of reports. A wide range of injuries have been reported with the MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea, dizziness, nodules, and chest pain, it adds.

[Last year](https://www.fdaweb.com/philips-discussing-consent-decree-over-respironics-recalls/), Philips said it is undergoing discussions with the Department of Justice (DoJ) on behalf of FDA about the proposed terms of a consent decree involving the company’s troubled Respironics unit and its ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. In April, the company said it received a DoJ subpoena asking for information on the events that led to recent recalls of the devices ([see earlier story](https://www.fdaweb.com/justice-department-probe-on-philips-respironics-recall/)).