Philips complaint count increases
By HME News Staff
Updated 9:56 AM CST, Mon February 13, 2023
AMSTERDAM – Philips says it filed about 78,800 complaints with the U.S. Food and Drug Administration between April 2022 and December 2022 that were allegedly associated with possible foam degradation in recalled CPAP, BiPAP and ventilator devices.
The company says most of these medical device reports (93%) were due to alleged technical malfunctions that do not involve serious injury.
“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. Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in certain of these MDRs.”
Previously, from April 2021 to April 2022, Philips filed about 20,500 MDRs, it says.
In its own update, the FDA says Philips filed more than 77,000 MDRs that included 223 reports of deaths from May 1, 2022, through Dec. 31, 2022.
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