Description of Event or Problem · 1
46 YEAR OLD FEMALE, WITH H/O ASTHMA ADMITTED TO ICU. PATIENT DEVELOPED SEVERE S.O.B., UNRESPONSIVE TO THERAPY. INTUBATED SEVERAL HOURS LATER PATIENT NOTED TO HAVE A LOW TIDAL VOLUME, RESPIRATOR CHECKED FOUND SATISFACTORY. PATIENT RE-INTUBATED X 3. SUBSEQUENTLY FIBEROPTIC BRONCHOSCOPY REVEALED A LACERATED TRACHEA. PATIENT'S CONDITION DETERIORATED. ACLS FUTILEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: MANUFACTURING, TELEMETRY FAILURE, PILOT BALLOON VALVE. CONCLUSION: DEVICE FAILURE INDIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, DEVICE TEMPORARILY REMOVED FROM SERVICE, NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.