FDA issues Class 1 recalls for two ventilator models

Editor's Note

Alarm failures and missing details in instructional materials prompted the US Food and Drug Administration (FDA) to issue class 1 recalls—the most severe category indicating risk of serious injury or death—for two different ventilator models on June 27.

According to the report, 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. So far, there have been 65 reports of death due to these issues as well as 952 reported injuries. A March 26 letter advised customers to remove patients from the device and connect them to an alternative source of ventilation in the event of an alarm.

Meanwhile, Zoll Medical Corporation is updating use instructions for 732 AEV, EMV+, and Eagle II ventilators to prevent misuse and failure due to instructions in the operator’s guide that may lead users to place the devices too close to Magnetic Resonance Imaging (MRI) equipment. Although no injuries or deaths have been reported, this could cause malfunctions or shutdowns that result in lack of oxygen, difficulty breathing, organ damage, and death, FDA reports. Users are advised to dispose of old manuals and request replacements.