WASHINGTON, D.C. — Not long ago, the U.S. Food and Drug Administration (FDA) determined that ResMed’s Stellat invasive and non-invasive ventilator recall initiated should be designated a Class I recall. A Class I recall is the most urgent recall designated by the FDA and denotes that the defect in the device could cause severe injuries or death. According to MassDevice.com, one person died as a consequence of the error found in the ResMed ventilator devices. There was no information regarding the number of injuries the defect might have caused. The fault that necessitated the recall is in the power switch. ResMed continues to stress that all of their medical devices are safe to use, as indicated.
ResMed’s Stellar invasive and non-invasive ventilators contain a sound alarm. The alarm should sound if the ventilator has an electrical problem, has been stored for longer than 36 hours with AC power, or the machine powers on automatically without depressing the power switch. The FDA indicated that 69 devices are affected by this recall.
ResMed sent a Field Safety Notification to its customers, advising them how to handle the situation. In its correspondence with customers dated December 5, 2019, ResMed said customers should refrain from using the recall Stellar ventilators on patients who must have a ventilator to survive. Also, ResMed noted that the user should perform a function test to confirm the necessary alarms are working. Finally, ResMed advised its customers to focus on the user and clinical guides as they relate to the company’s recall campaign. ResMed did not offer a repair solution to the problem.
ResMed recalled Model Number 100 and 150 within the serial number range 20160123307 to and including 22171057208. ResMed manufactured the defective ventilators from April of 2016 to June of 2018. ResMed distributed the recalled devices from April of 2016 to November of 2017.
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