CareFusion Corporation EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation
11/7/2011 9:31:37 AM
Friday, November 4, 2011 -- AUDIENCE: Critical Care Medicine, Risk Manager. ISSUE: 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.