Philips recall: FDA continues review of medical device reports 

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 or suspected foam breakdown from April 2021 through April 2022. 

The FDA says its 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 MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers and patients. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules and chest pain. 

Although MDRs are a valuable source of information, the FDA acknowledges this passive surveillance system has limitations. It says the incidence, prevalence or cause of an event cannot typically be determined from this reporting system alone, due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Because of these limitations, it says the MDRs comprise only one of several important post-market surveillance data sources. 

The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available.