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Philips updates complaint count 

Philips updates complaint count 

AMSTERDAM – Philips Respironics filed an additional 70,000 medical device reports (MDRs) with the U.S. Food and Drug Administration between April 2022 and October 2022, the company stated in a Nov. 22 update on its recall of certain CPAP, BiPAP and mechanical ventilator devices. 

The vast majority of the 90,000 MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury, the company stated.  

“It is important to note that the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event, and that the cause of an event cannot typically be determined from this reporting system alone,” the company stated. “Philips Respironics investigates all allegations of technical malfunction, serious injury or death.” 

Philips noted that, following public statements on the potential health risks related to the polyester-based polyurethane (PE-UR) sound abatement foam in certain devices in April 2021 and the announcement of the recall in June 2021, the company received a steep increase in complaints. 

In its announcement, the FDA noted that 260 deaths were included in the 90,000 MDRs.  

  • Read about how Philips recently paused its remediation program for recalled vents to investigate a limited number of complaints. 
  • As of November 2022, the company was still in talks with the U.S. Department of Justice on a consent decree to resolve identified issues related to its recall.   


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