CareFusion EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation
MedSun: Newsletter #67, December 2011
FDA MedWatch Safety Alert
FDA notified healthcare professionals of a Class I recall of all EnVe Ventilator model 19250-001, manufactured between December 2010 and May 2011, due to potential defects that can interrupt ventilation to the patient. The issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection during transport. Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death. CareFusion is contacting facilities to coordinate hardware and software updates for affected ventilators.
FDA MedWatch Safety Alert. CareFusion EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation. November 4, 2011.