FDA: Ventilator death, injury reports lower than initially reported

Editor's Note: 

Problems with Philips’ BiPap V30, BiPAP A30, BiPAP A40 ventilators resulted in only 7 recorded deaths and 10 injuries—far fewer than the 65 deaths and 952 injuries initially reported by the US Food and Drug Administration (FDA).

In a July 10 update to the class 1 recall—the most severe category indicating risk of serious injury or death—FDA noted “a total of 911 reports reportedly associated with the recall issue (ventilator inoperative): 894 are malfunctions.”

The BiPAP V30 Auto ventilator provides non-invasive support for adults and children over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA) and respiratory insufficiency. As we reported June 28, failure in the Ventilator Inoperative alarm on Philips Respironics’ BiPAP V30, A30, and A40 ventilators can lead to intermittent rebooting, sometimes with factory default settings and sometimes with patient-specific settings, and eventual shutdown after three reboots in 24 hours. This can result in hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients.