CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation
MedSun: Newsletter #68, January 2012
FDA MedWatch Safety Alert
FDA notified healthcare professionals of a class I recall of CareFusion AVEA Ventilators. The AVEA ventilator can develop a failure where the ventilator activates a false extended high peak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer life-threatening injury or death. The AVEA ventilator is intended for continuous breathing support for the care of neonatal through adult patients who require mechanical ventilation. These ventilators are used in hospitals and other health care institutions. The recalled ventilators were manufactured between March 1, 2009 and June 30, 2011.
FDA MedWatch Safety Alert. CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation. December 23, 2011.