The FDA issued an update to its communication on Philips Respironics’ ventilator recall confirming the reports of 44 more deaths.
Last year, Amsterdam-based Philips (NYSE:PHG) Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.
At the time, the company stopped taking orders of sleep therapy systems as it handled the Class I recall. In March of this year, the FDA told Philips that its notification efforts on the recall of its ventilators had been inadequate to that point.
In April, the company revealed a Department of Justice subpoena for information related to the recall of its respiratory devices. The subpoena sought “information related to events leading to the Respironics recall.” Phillips said its subsidiaries are cooperating with investigators.
On May 2, the FDA’s Center for Devices and Radiological Health (CDRH) proposed an order for Philips to submit a plan for the repair, replacement or refund of the purchase price of the recalled devices manufactured after November 2015. Later that month, the agency confirmed that it received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown in Philips Respironics’ ventilator devices between April 2021 and April 30, 2022.
The FDA’s latest update includes data from the period that followed the first time frame, with more than 48,000 MDRs and 44 reports of death associated with the PE-PUR foam breakdown or suspected foam breakdown between May 1, 2022, and July 31, 2022. That brings the total MDR tally to more than 69,000 and the reported death total to 168.
Philips submitted 30 MDRs between 2011 and April 2021 that were identified as associated with the PE-PUR foam breakdown, with eight of those coming from the U.S. In that period, there were no reports of patient injury or death.
“The FDA’s 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 FDA notice said. “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.”