In November and December, Philips reported 8,000 new patient problems that could be caused by faulty sleep apnea devices. In 82 of those cases there was a death, reports the US medical device regulator FDA.
The problems with the sleep apnea machines revolve around the insulating foam in the machines. This could crumble or release chemicals after contact with certain cleaning agents, possibly resulting in damage to health. In total, Philips has to replace 5.5 million devices because of the defect.
No convincing evidence
Philips emphasizes in its own update that more than ninety percent of the 99,000 reports of incidents reported since April 2021 had no serious consequences. In addition, a report of an incident after using the equipment in question does not immediately say that there is a connection between the two, the medical technology group from the Netherlands emphasizes.
A total of 346 deaths have been reported that may have been related to the faulty devices. Philips says it is investigating all those reports, but has not found any convincing evidence to date that links those deaths to the technical problems.