POSITIVE PRESSURE VENTILATOR

Description of Event or Problem

VENTILATOR WAS "BLACKED OUT", NOT OPERATING AND READY"ERROR 1501" WITH NO ALARMS. PATIENT MAY HAVE BEEN COMPROMISED. SERVICE REPRESENTATIVE HAS BEEN CALLED IN AND IS DOING A DIAGNOSTIC EVALUATION.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-APR-93. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.