Tag: MDRs
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...