FDA gets over 48K new reports of defective Philips respiratory systems from May-July
Aug. 17, 2022 6:01 AM ETKoninklijke Philips N.V. (PHG)By: Ravikash, SA News Editor1 Comment
- The U.S. Food and Drug Administration (FDA) said it received more than 48,000 reports of faulty Philips (NYSE:PHG) ventilators and respiratory devices between May and July, which included 44 reports of death.
- The 48K medical device reports (MDRs) from May 1 to July 31, was more than twice the number (more than 21K MDRs) received by the agency across a year (from April 2021 through April 30, 2022) and included 124 reports of death associated with breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam.
- The FDA said its review of these new MDRs will include examining the possible reasons for the increased number of reports during this time.
- A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain, the FDA said in an Aug. 16 release.
- The FDA noted that in June 2021, Philips had recalled certain ventilators, BiPAP machines, and CPAP machines because of potential health risks. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down, which can cause foam or certain chemicals to be breathed in or swallowed by the person using the device. These issues could potentially result in serious injury.
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