ResMed Recalls Astral 100, 150 Ventilators

ResMed Ltd. has recalled (Class 1) its Astral 100 and Astral 150 ventilators due to what FDA calls a “device design” issue. If an affected ventilator is running on its internal battery, which is not intended to serve as a primary power source, the device’s low/critically low battery alarms will sound and a fault could lead to a sudden power loss, a recall notice says. If the power fails, then ventilation stops and a total power failure (TPF) alarm should sound. But because the device is powered by a supercapacitor, which can degrade over time, the TPF alarm could sound for less than two minutes or not at all, it says.

The company says that a recent Field Safety Notice was emailed to distributors, institutions, and medical facilities. The notice recommends that users continue to use the ventilator and to connect the devices to main power supplies whenever possible.