Philips sends more MDRs to FDA
By HME News Staff
Updated 8:20 AM CST, Mon February 5, 2024
WASHINGTON – Philips has submitted more than 7,000 medical device reports, including 111 reports of death, for July 1, 2023, to Sept. 30, 2023, that are associated with the breakdown or suspected breakdown of the foam used in the ventilators and BiPAP and CPAP devices included in its large recall, according to the U.S. Food and Drug Administration. Since April 2021, the company has submitted more than 116,000 MDRs, including 561 reports of death, reportedly associated with the breakdown or associated breakdown of the foam. The FDA says the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. Philips Respironics says it investigates all received complaints and allegations of malfunction, serious injury or death, and based on the investigations to date, it has found no conclusive data linking these devices and the deaths reported in these MDRs. The company recently announced that it has agreed on the terms of a multi-year consent decree with the FDA related to the recall. As part of the consent decree, the company will not sell new CPAP or BiPAP devices or other respiratory devices in the U.S. Philips has stated, however, that it is committed to resuming sales, once the relevant requirements of the consent decree are met.
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