The US Food and Drug Administration (FDA) said reports of faulty Philips ventilators and sleep apnea machines had risen in the past quarter, underlining problems facing the Dutch company, which has just announced plans to replace its CEO.
According to a Reuters report, Philips says it is approximately halfway through a recall of 5.5m such devices in the United States due to the threat posed by a foam part they contain, a problem that has alarmed customers, damaged the company's reputation and helped wipe $30bn off its market capitalisation.
The FDA said on Tuesday it had received 48 000 reports associated with breakdown or suspected breakdown in the foam used in Philips respirators over the three months ending 31 July, more than twice the number of such reports it received between April 2021 and April 2022.
"A wide range of injuries have been reported in these (reports) including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, difficulty breathing, dizziness, nodules, and chest pain," the FDA said. The reports are not proof that Philips devices were responsible.
A spokesperson for Philips today said the timing of the 16 August FDA update (the same day that Philips announced longtime CEO Frans van Houten would depart the company) was coincidental.
Van Houten will be replaced by Roy Jakobs, the Philips executive who is heading the company's recall operation, on 15 October.
Spokesman Steve Klink said the increase in reports was due to increased public awareness of the problem after its recall began in June 2021.
Reuters: fda-says-faulty-philips-device-reports-accelerating-ceo-departs