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Tag: medical device reports


Vendors

Philips updates complaint count 

November 28, 2022HME News Staff

AMSTERDAM – Philips Respironics filed an additional 70,000 medical device reports (MDRs) with the U.S. Food and Drug Administration between April 2022 and October 2022, the company stated in a Nov. 22 update on its recall of certain CPAP, BiPAP and mechanical ventilator devices.  The vast majority of the 90,000 MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury, the company stated.   “It is important to note that the submission...

Complaints, MDRs, medical device reports, Philips Respironics


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Vendors

Philips recall: FDA continues review of medical device reports 

August 22, 2022HME News Staff

WASHINGTON – The U.S. Food and Drug Administration updated its safety communication for the Philips recall this month, saying it received more than 48,000 medical device reports, including 44 reports of death, associated with the foam breakdown or suspected foam breakdown in certain CPAP devices from May 1, 2022, through July 31, 2022.  The agency previously reported in May that it received more than 21,000 MDRs, including 124 reports of death, associated with the foam breakdown...

CPAP Devices, medical device reports, Philips Recall


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