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# Respironics Ventilator MDRs Increase
- URL: https://www.fdaweb.com/respironics-ventilator-mdrs-increase/
- Published: 2022-08-17T12:00:00.000Z
- Updated: 2026-09-14T17:56:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152527

FDA says that between 5/1 and 7/31 it has received more than 48,000 medical device reports (MDRs), including 44 reports of deaths, associated with polyester-based polyurethane (PE-PUR) sound abatement foam degradation in certain Philips Respironics ventilators and other medical devices. The agency’s 8/16 [report](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) update says that since 4/2021, when Philips first notified FDA of its intention to conduct a field action due to concerns about foam degradation, the agency has received more than 69,000 MDRs, including 168 reports of deaths associated with the foam breakdown.

“FDA’s in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports during this time,” the update says…. “A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea, dizziness, nodules, and chest pain.”

The company’s 6/14/21 Class 1 [recall](https://www.fdaweb.com/class-1-recall-for-philips-respironics-ventilators/) of ventilators, CPAP, and BiPAP machines is now the subject of consent decree [talks](https://www.fdaweb.com/philips-discussing-consent-decree-over-respironics-recalls/) with the Justice Department and FDA.