Dive Brief:
- The Food and Drug Administration said it received 44 reports of death associated with the breakdown or suspected breakdown of foam in Philips respiratory devices from May 1 to July 31, 2022.
- In the three-month period, the agency received more than 48,000 medical device reports (MDRs) related to the issue, which affects certain ventilators and sleep apnea machines and spurred a global recall.
- The number of MDRs submitted to the FDA recently has accelerated, with the agency receiving more than twice as many reports from May to July than it did from April 2021 to April 2022. The regulator said it will carry out an in-depth review to find possible reasons for the increase in reports.
Dive Insight:
The FDA, in its previous report, said it received more than 21,000 MDRs, including 124 reports of death, associated with the breakdown or suspected breakdown of PE-PUR foam in certain Philips devices 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 steep increase in complaints allegedly associated with possible foam degradation.”
The company said it filed 30 MDRs 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 health professionals, consumers and patients, according to the FDA. Reported injuries reported include cancer, pneumonia, asthma, infection, headache, cough, difficulty breathing, dizziness, nodules and chest pain.
The FDA has cautioned that under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event and a lack of information about details such as frequency of device use typically prevent the determination of the incidence, prevalence or cause of an event from MDRs. Still, the agency said the jump in reports spurred it to investigate the matter.
The probe into the increase in reports comes as Philips talks to the U.S. Department of Justice about a consent decree and seeks to complete a recall that has handed an opportunity to rival ResMed. Responsibility for getting the business back on track will fall on Roy Jakobs, head of Philips’ Connected Care business, who is set to replace Frans van Houten as CEO. Philips announced on Tuesday that van Houten will step down in October.
