Description of Event or Problem · 1
UNIT HAD BEEN RUNNING CONTINUOUSLY FOR 6 HOURS, THAT DAY WHEN THE UNIT WENT INTO ALARM AND DISPLAYED POWER FAIL SYMPTOMS. THERE WERE NO UNUSUAL EVENTS PRECEDING THIS ANYWHERE IN THE FACILITY. ALL INDICATIONS ARE THAT THIS IS AN INTERNAL MALFUNCTION OF THE POWER SUPPLY. THE SAME TYPE OF EVENT OCCURRED FOUR MORE TIMES DURING THE THREE HOUR TREATMENT OF THIS PT. ON THE FIFTH OCCURRENCE, THE NURSE REMOVED THE PT FROM THIS UNIT AND THIS UNIT WAS REMOVED FROM SERVICE. OPERATION OF THE UNIT SUBSEQUENT TO THE EVENT COULD NOT DUPLICATE THE PROBLEM. CUSTOMER SERVICE AT CO WAS CONTACTED AND OFFERED NOT APPRECIABLE CONTRIBUTION TO A SOLUTION TO THE PROBLEM.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-SEP-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, COMPUTER HARDWARE PERFORMANCE TESTS CONDUCTED, COMPUTER SOFTWARE PERFORMANCE TESTS CONDUCTED, ELECTRICAL TESTS PERFORMED. RESULTS OF EVALUATION: ELECTRICAL PROBLEM, TELEMETRY FAILURE, POWER SUPPLY. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.