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Philips recall: FDA reviewing, assessing medical device reports 

Philips recall: FDA reviewing, assessing medical device reports 

WASHINGTON – The U.S. Food and Drug Administration says it received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the foam breakdown or suspected foam breakdown of recalled Philips BiPAP and CPAP devices.

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

“Although MDRs are a valuable source of information, this passive surveillance system has limitations,” the agency stated. “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 frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important post-market surveillance data sources. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment.” 

Manufacturers like Philips are required to submit MDRs when information reasonably suggests that their device may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device they manufacture would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. 

Philips submitted 30 MDRs between 2011-2021 that the company identified as associated with the PE-PUR foam breakdown, with no reports of patient injury or death, according to the FDA. 

In an update posted May 24, the company said at the time the recall notification/field safety notice was issued, it relied on an initial, limited data set and toxicological risk assessment, and assumed a reasonable worst-case scenario for the possible health risks. Following its public statements on the issue and possible risks to users in April 2021, and the announcement of the recall notification/field safety notice in June 2021, it received a steep increase in complaints allegedly associated with possible foam degradation. 

“We regret any concern or inconveniences caused by this field action and we are committed to supporting the community of patients who rely on our sleep and respiratory care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs,” said David Ferguson, business leader of Philips Respironics. “We are replacing or repairing the devices related to the Respironics field action as fast as possible and are continuing to update patients and customers about the progress of the program. More than 1,000 of our colleagues are working around the clock on every aspect of the remediation.” 


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