Two weeks after posting about alarm issues with some Philips Respironics ventilators, the FDA clarified July 10 there have been seven reports of death, not 65.
In a June 27 statement, the agency said there were reports of 952 injuries and 65 deaths related to inoperative alarms in Philips' BiPAP V30, BiPAP A30 and BiPAP A40 ventilators. The devicemaker told Becker's at the time it "does not recognize these numbers" and that the serious injury reports have been accrued between 2011 and 2023.
In a corrected statement, the FDA said there are 911 reports associated with the problem, including 894 malfunctions, 10 injuries and seven deaths.
Philips notified customers of the 100,000-some ventilators about the problem in late March.
The devices are not being removed from the market, but the FDA classified the warning as a Class I recall because of the health risks, including hypoventilation, hypoxemia, hypercarbia, respiratory failure and death.
"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."