Engstrom Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action
MedSun: Newsletter #89, November 2013
FDA MedWatch Safety Alert
GE Healthcare has initiated a voluntary field corrective action due to a potential safety issue that involves unresponsive buttons on the display of the Engström ventilator and Aespire View, Aisys, and Avance anesthesia machines. Due to a manufacturing issue the buttons on the left, right, and bottom keypads may not always detect a user’s button presses. This may result in the inability to access certain menu functions which could possibly lead to delay in treatment. To date, no patient injuries have been reported with regards to this issue.
Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action. FDA MedWatch Safety Alert. October 16, 2013.