Philips Respironics’ Alleged Mishandling of Safety Concerns: New Insights EmergePhilips Respironics’ Alleged Mishandling of Safety Concerns: New Insights Emerge

An investigative report from the Pittsburgh Post-Gazette exposes internal fights and resignations over the company’s refusal to stop making dangerous breathing machines.

Amanda Pedersen

July 11, 2024

2 Min Read
DreamStation CPAP sleep apnea machine manufactured by Philips, part of the company's massive June 2021 recall of respiratory devices.
The company's DreamStation CPAP machine was among the breathing machines included in Philips' June 2021 recall.Image courtesy of Philips Respironics

The same investigative journalists who took Philips to task last year for waiting 11 years before coming forward with its respiratory device problem, recently revealed new insights into the saga.

The latest Philips report from the Pittsburgh Post-Gazette suggests, based on “newly obtained documents” that there were internal fights and resignations over safety standards during the pandemic and whether actions would tip off federal regulators.

The report tells the story of Hisham Elzayat, MD, who arrived at Philips as a medical director four years ago. The heart surgeon reviewed complaints about the company’s respiratory devices and met with the company’s top biosafety engineer who allegedly shared the doctor’s complaints.

According to the article, Elzayat began pushing the company to halt shipping of the devices in June 2020, but the company not only turned down his request but chose instead to ratchet up sales of its ventilators and sleep apnea machines during the COVID-19 pandemic.

The Post-Gazette journalists report that Elzayat has turned over hundreds of pages of company emails, text messages, and reports to federal prosecutors as part of the ongoing criminal investigation of the leadership of the company.

“The confidential documents, which have been obtained by the Post-Gazette, show for the first time the surgeon was among nearly a dozen Philips engineers and others who pushed the company to warn patients about the dangers of the foam before Philips removed millions of the devices from the market in a recall in June 2021 and to later stop the company from downplaying the risks.

The Justice Department reportedly declined to comment on the probe, but experts interviewed by the Post-Gazette say the internal correspondence could provide key information for investigators in assessing when top leaders learned of the deficiencies and whether they concealed the dangers. Read the Post-Gazette’s full story here.

About the Author

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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