FDA issues Class I recall for Philips BiPAP ventilators

Editor's Note

Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss.

As detailed in the agency’s July 4 announcement, these failures can cause therapy interruption, which may lead to hypoventilation, hypoxemia, hypercarbia, respiratory failure, or death in vulnerable patients. There have been 13 reported injuries. There have been eight reports of death.

If a Ventilator Inoperative alarm occurs and therapy interruptions can be tolerated, patients or caregivers should remove the patient from the device and place them on an alternative device. If interruptions cannot be tolerated, alternate ventilation should be provided and the equipment supplier should be contacted. The full FDA announcement includes additional steps, contact information, and identifying information for affected models.