FDA Received More Medical Device Reports For Philips June Recall

The FDA has received 44 further reports of deaths associated with certain Philips ventilators, BiPAP and CPAP machines recalled in June 2021, it said in an Aug. 16 update.

• Between May 1 and July 31 the FDA received more than 48,000 Medical Device Reports (MDRs), including 44 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown
  • Since April 2021, the FDA has received more than 69,000 MDRs, including 168 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown
• NOTE: Philips previously said submission of an MDR itself is not evidence that ...