The sound alarm on the ventilators may not work if the device has a failed electronic part, is stored without AC power for more than 36 hours, and powers on automatically when connected to AC power without pressing the power switch, according to FDA.
The agency said that there has been one reported death related to the recall.
The Stellar ventilators either push air non-invasively, with air coming through a mask or mouthpiece, or invasively, with air going through a tube into the windpipe. They’re meant to provide breathing support in both hospital and home settings for people are who are non-ventilator dependent and spontaneously breathing.
Stellar ventilators in the recall include Model Numbers 100 and 150 with serial number range 20160123307 to 22171057208 — made between April 2016 and June 2017 and distributed between April 2016 and November 2017. There are 69 ventilators involved in the recall, according to FDA.
ResMed sent a Field Safety Notification to customers on Dec. 5, 2019. Instructions in the notification included:
- Not using affected Stellar ventilators on people who cannot have any breaks in breathing support or need a ventilator for life support;
- Performing a function test that includes the use of alarms prior to each use;
- Especially focusing on the sections of the Stellar user and clinical guides related to the recall.
When contacted by MassDevice, a ResMed spokesman stressed that all Stellar devices, including those involved with this Field Safety Notice, are safe to use for all indicated uses.