FDA reviews rise in reports of Philips respirators, including 44 deaths

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Diving Brief:

  • The Food and Drug Administration said it received 44 death reports associated with the failure or suspected failure of foam in Philips respirators from May 1 to July 31, 2022.
  • During the three-month period, the agency received more than 48,000 medical device reports (MDRs) related to the issue, which affects some ventilators and sleep apnea devices and has spurred a global reminder.
  • The number of MDRs submitted to the FDA has recently accelerated, with the agency receiving more than twice as many reports from May to July as from April 2021 to April 2022. The regulator said it would conduct a thorough review to find possible reasons for the increase in reports.

Overview of the dive:

The FDA, in its previous reportsaid it received more than 21,000 MDRs, including 124 fatality reports, associated with the failure or suspected failure of PE-PUR foam in certain Philips appliances from April 2021 to April 30, 2022.

A Philips spokesperson wrote in an email that after the company’s public statements in April 2021 and a recall notification two months later, Philips received “a sharp increase in complaints allegedly associated with possible foam degradation.

The company said it filed 30 LOL related to the issue from 2011 to April 2021, and filed more than 68,000 between April 2021 and July 2022.

Some of the new MDRs are mandatory reports from Philips, while others are voluntary reports from healthcare professionals, consumers and patients, according to the FDA. Reported injuries include cancer, pneumonia, asthma, infections, headaches, coughing, difficulty breathing, dizziness, lumps and chest pain.

The FDA warned that under-reporting of events, inaccuracies in reporting, lack of verification that the device caused the reported event, and lack of information on details such as frequency of use of the devices generally prevent the determination of the incidence, prevalence or cause of an MDR event. Still, the agency said the increase in reports prompted it to investigate the matter.

The investigation into the increase in reports comes as Philips talk to the U.S. Department of Justice regarding a consent decree and is seeking to complete a recall that handed an opportunity compete with ResMed. Responsibility for getting the business back on track will fall to Roy Jakobs, head of Philips’ Connected Care business, who is ready to replace Frans van Houten as CEO. Philips announced on Tuesday that van Houten will step down in October.

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