Description of Event or Problem · 1
THE PATIENT WS CONNECTED TO THE BUNNELL HFJV (IN ADDITION TO BEING CONNECTED TO THE BEAR CUB VENTILATOR) AND IT WAS NOTED THAT THERE WAS EXCESSIVE WATER IN THE HUMIDIFIER CIRCUIT TUBE. THE CIRCUIT TUBE WAS DISCONNECTED FROM THE PATIENT AND THE RT SUCTIONED THE PATIENT. DURING THE RECONNECTION TO THE BUNNELL HFJV, THE PIP INCREASED BEYOND THE ORIGINAL SETTING (27 CM H-2-O). ABUNDANT CHEST WALL MOVEMENT WAS NOTED. THE RT REACHED TO TURN DOWN THE PIP SETTING TO 22 CM H-2-0 AND AT THIS SAME TIME THE PIP INCREASED TO A MAX OF 57 CM H-2-0. THE PATIENT WAS IMMEDIATELY DISCONNECTED FROM THE BUNNELL HFJV AND WS BAGGED AS THE PATIENT BECAME BRADYCARDIC. THE PATIENT WAS NOT RESPONSIVE TO THE CPR. THE DEVICE WAS SENT TO A THIRD PARTY FOR EVALUATION. THE EVALUATION CONFIRMED THROUGH AN OPERATIONAL PERFORMANCE VERIFICATION THAT THE PIP PRESSURE RISES UNCONTROLLABLYDEVICE 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: . SERVICE PROVIDED BY: MANUFACTURER. 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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.