Description of Event or Problem · 1
PATIENT PRESENTED IN THE ENMERGENCY DEPARTMENT WITH CARDIOPULMONARY RESUSCITATION IN PROGRESS. EKG PER PADDLES SHOWED QRS-COMPLEX WITHOUT PULSE AND PUPILS FIXED. WITH INITIAL INTUBATION USING ET TUBE, BALLOON WOULD NOT INFLATE. ETT WAS REMOVED AND CHECKED, AND BALLOON STILL WOULD NOT INFLATE. A SECOND ATTEMPT WITH ANOTHER ETT WAS SUCCESSFULLY PLACED AND INFLATED. RESUSCITATIVE MEASURES WERE DISCONTINUED NINE MINUTES AFTER ADMISSION TO ED, PATIENT EXPIREDDEVICE 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, MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, PILOT BALLOON VALVE. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, DEVICE DISCARDED - UNABLE TO FOLLOW-UP. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.