Description of Event or Problem · 1
THE PRODUCT WAS USED IN A 56 YEAR OLD MALE IN RESPIRATORY DISTRESS. THE STAFF NOTED WHAT APPEARED TO BE A CUFF LEAK. WHEN ATTEMPTS TO PREVENT AIR FROM LEAKING FAILED, THE STAFF FELT IT APPROPRIATE TO REPLACE THE TUBE. UPON REMOVING THE TUBE, THE PATIENT EXPERIENCED SEVERE RESPIRATORY DISTRESS AND DID NOT TOLERATE THE RE-INTUBATION. UPON EXAMING THE REMOVED TUBE, IT WAS NOTED THAT THE PILOT TUBE WAS SEVERED FROM THE REST OF THE ET TUBEDEVICE 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, A DEVICE FROM SAME LOT WAS EVALUATED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER, PILOT BALLOON VALVE. CONCLUSION: USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.