The FDA received a total of 6,000 medical device reports (MDRs) between January 1, 2023, and March 31, 2023, related to the PE-PUR foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. These MDRs included 40 reports of death.
According to an updated safety communication, the FDA is not changing recommendations from its June 2021 safety communication for use of the recalled devices.
Since April 2021, the FDA has received more than 105,000 MDRs, including 385 reports of death, reportedly associated with the recalled devices’ PE-PUR foam breakdown or suspected foam breakdown.
The FDA says its in-depth review and analysis of the new MDRs will include examining the possible reasons for the increased number of reports. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. A wide range of injuries has been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.
Additional safety communications may be issued as the FDA continues to review and assess the MDRs related to the Philips recall to keep the public informed as new information becomes available.