Description of Event or Problem · 1
EEG TECHNICIAN CALLED TO REPORT A PROBLEM WITH NEUROSCOPE.TECH REPORTED THAT MACHINE CAUSED A BURN ON PATIENTS ANKLE. BIOMEDICAL STAFF INSPECTED THE MACHINE BY PHYSICALLY TESTING THE STIMULATOR AND NOTING THAT THE OUTPUT WOULD DECREASE AT SOME SETTINGS AND CAUSE TINGLING AT OTHERS. GROUNDING CONTINUITY AND INTEGRITY WAS VERIFIED FROM STIMULATOR TO CHASSIS AND FROM CHASSIS TO GROUND WHICH WAS ALL RIGHT. OPEN CIRCUIT CONSTANT CURRENT WAS MEASURED AT 13.8 MA.DEVICE 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-APR-93. 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, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. 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, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.