FDA updates Philips report count
By HME News Staff
Updated 9:51 AM CDT, Tue June 6, 2023
AMSTERDAM – The U.S. Food and Drug Administration received more than 6,000 medical device reports (MDRs) associated with the PE-PUR foam degradation in certain recalled Philips CPAP and BiPAP machines and ventilators from Jan. 1, 2023, through March 31, 2023, including 40 reports of death. 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. The FDA says, although MDRs are a valuable source of information, this passive surveillance system has limitations. 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 this, MDRs comprise only one of the FDA's several important post-market surveillance data sources. Since April 2021, the FDA has received more than 105,000 MDRs, including 385 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown.
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