Description of Event or Problem · 1
ANESTHESIA WAS IN PROGRESS ON A PATIENT (GENERAL ANESTHESIA). DECISION TO USE THE ANESTHESIA VENTILATOR WAS MADE. VENTILATOR PRESSURE WOULD GO ONLY TO 300. VENTILATOR TURNED OFF AND BAG VENTILATING BREATHING RESUMED WHILE SOURCE OF PROBLEM HUNTED. A HOLE IN THE BREATHING CIRCUIT WAS DISCOVERED. NO PATIENT INJURY: ALL ANESTHESIA PARAMETERS WITHIN NORMAL LIMITS, I.E. OXYGEN SATURATION AND CO2 MONITORING. NEW CIRCUIT PUT IN PLACE. ANESTHESIA VENTILATOR RESUMED WITH PROPER VENTILATION LEVELS ATTAINABLEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.