The FDA issued a clarification that significantly trims the number of deaths reportedly associated with a recall of Philips Respironics ventilators.
On June 28, the FDA issued a Class I recall notice involving potential Ventilator Inoperative alarm failures on BiPAP V30, BiPAP A30, BiPAP A40 devices. At the time, the FDA cited 952 reports of injuries and 65 reports of death related to the recall.
However, the agency clarified on July 10 that it received seven reports of death, not 65. It amended its original numbers to 911 reports associated with the problem, including 894 malfunctions and 10 injuries.
Philips originally notified customers on March 26. It has not removed devices from the market, but the FDA labeled the recall serious because of potential risks that include hypoventilation, hypoxemia, hypercarbia, respiratory failure and death. The recall instead involved updating instructions for use with the devices.
“There have been reports of potential patient harm. Investigation of these reports could not conclusively determine causation,” the company said in late June. “Philips Respironics is currently investigating this issue and will implement appropriate actions.”
The FDA shared a statement with MassDevice via email regarding the correction:
“The number of injuries and deaths reportedly associated with this Philips recall has been reevaluated and corrected in the recall summary.
Upon further review, the FDA determined that the original MDR numbers posted in the recall summary were based on an incomplete analysis the agency had performed of the MDRs reportedly associated with this recall. We regret the error, and it has been corrected and the recall summary updated.”
