Description of Event or Problem · 1
THE LOCKING PLATES WHICH SECURED THE FOOT REST TO THE TABLE IN ONE OF THE HOSPITAL'S FLUROSCOPY ROOMS DISENGAGED WHILE SUPPORTING A PATIENT'S WEIGHT RESULTING IN THE PATIENT FALLING TO THE FLOOR. THE OCCURENCE WAS REPORTED TO THE MANUFACTURER, WHO MADE A SITE VISIT ON DECEMBER 21, 1992. ADJUSTMENTS WERE MADE TO THE FOOT BOARD. IT WAS ALSO NOTED THAT THERE WAS A PROBLEM WITH THE FOOT BOARD U-CHANNELS BENDING. THIS WILL BE REPORTED TO THE MAIN COMPANY HEADQUARTERS IN GERMANYDEVICE 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-NOV-91. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, DESIGN - INADEQUATE, MATERIAL DEGRADATION/DETERIORATION. 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, DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.