Tag: Medical Device Reports (MDRs)
Philips sends more MDRs to FDA
February 5, 2024HME News Staff
WASHINGTON – Philips has submitted more than 7,000 medical device reports, including 111 reports of death, for July 1, 2023, to Sept. 30, 2023, that are associated with the breakdown or suspected breakdown of the foam used in the ventilators and BiPAP and CPAP devices included in its large recall, according to the U.S. Food and Drug Administration. Since April 2021, the company has submitted more than 116,000 MDRs, including 561 reports of death, reportedly associated with the breakdown or...
Philips complaint count increases
February 13, 2023HME News Staff
AMSTERDAM – Philips says it filed about 78,800 complaints with the U.S. Food and Drug Administration between April 2022 and December 2022 that were allegedly associated with possible foam degradation in recalled CPAP, BiPAP and ventilator devices.
The company says most of these medical device reports (93%) were due to alleged technical malfunctions that do not involve serious injury.
“It is important to note that the submission of an MDR itself is not evidence that...
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...
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...