Philips failed to report, investigate death of sleep apnea patient in Netherlands

Philips failed to report or investigate the death of a Dutch patient who used one of its sleep apnea devices, NRC reports based on a letter from the patient’s sons to the Philips management. Philips thereby violated European legislation for medical devices.

The sons wrote that the 65-year-old teacher from Oosterbeek died of the rare lung disease idiopathic pulmonary fibrosis. They expressly linked his death to his years-long use of a Philips Dreamstation - one of the sleep apnea devices Philips recalled in 2021 after discovering that certain cleaning agents could degrade the sound-insulating foam, which could end up in patients’ lungs.

According to European legislation for medical devices, Philips should have forwarded the report to the Health and Youthcare Inspectorate and launched its own investigation into the device the patient used and how they used it.

A spokesperson for the Inspectorate told the newspaper that it didn’t receive “any reports of a death with the Philips Dreamstation.” Without information from Philips, the Inspectorate can’t investigate whether the company properly investigated the death, as required by law, the spokesperson said.

Philips’ marketing manager did send the patient’s sons the same interim report it posted on its website in December 2022. In that report, the company said that interim test results showed that it was “unlikely” that patients would suffer health damage due to sleep apnea devices. In May, the company said that most of its sleep apnea devices were safe to use.

A Philips spokesperson told NOS that “the process has not been followed properly, and we apologize for that.” The company has invited the patient’s loved ones for a meeting. “We’re eager to try to provide the answers they’re looking for.”