Description of Event or Problem · 1
NUCLEAR MEDICINE GAMMA CAMERA WAS SET UP TO DO A WHOLE BODY BONE SCAN AND WITHOUT OPERATOR COMMAND UNIT BEGAN TO ROTATE ON TO PATIENT. THE EMERGENCY STOP WAS UTILIZED BY THE TECHNOLOGIST TO PREVENT INJURY BUT NOT BEFORE CONTACT TO PATIENT WAS MADE. PATIENT WAS INITIALLY EXAMINED BY RADIOLOGIST TO DETERMINE EXTENT OF INJURY. NO APPARENT INJURY WAS OBSERVED AT THAT TIME. THREE DAYS LATER A FOLLOW-UP CALL WAS MADE BY SUPERVISOR IN NUCLEAR MEDICINE TO PATIENT WHO DESCRIBED A SMALLBRUISE ON PELVIS. PATIENT WAS BROUGH BACK AND EXAMINED AGIN BY RADIOLOGIST. NO DEEP INJURY WAS FOUND AND PATIENT WAS RELEASEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUN-92. 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: COMPUTER SOFTWARE PERFORMANCE TESTS CONDUCTED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.