Description of Event or Problem · 1
ON 5/10/93, THIS EQUIPMENT WAS TOBE USED FOR A CAROTID ANDX VERTEBRAL ANGIOGRAM. ON THE THIRD SET OF FILMS, THE EQUIPMENT FAULTED. ON TWO SUBSEQUENT SETS OF FILMS, THE EQUIPMENT FAILED AGAIN. THE PROCEDURE WAS THEN TERMINATED BY THE DOCTOR. THE PATIENT EXPERIENCED BLINDNESS AFTER THE PROCEDURE; IT DID CLEAR WITHIN 24 HOURSDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAY-93. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.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, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, INVALID DATA. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.