Description of Event or Problem · 1
DURING A TELEPHONE CONVERSATION ON DEC. 31, 1991 WITH THE HOSPITAL'S BIOMEDICAL ENGINEERING TECHNICIAN, I WAS INFORMED, FOR THE FIRST TIME, THAT ON DEC. 25, 1991 A PATIENT HAD BEEN MONITORED ON THE ATHENA MONITOR IN THE HOSPITAL'S ICU - ROOM #2. THE HOSPITAL HAD TURNED OFF THE BEDSIDE ALARMS DUE TO RUNNING OUT OF ATHENA RECORDER PAPER. THE PATIENT EXPERIENCED A "CODE" SITUATION, HOWEVER, SINCE THE BEDSIDE ALARMS HAD BEEN TURNED OFF, THE "CODE" SITUATION WAS NOT IMMEDIATELY APPARENT. THE PATIENT WAS CONSCIOUS AND TALKATIVE PRIOR TO THE "CODE", AFTER THE "CODE", THE PATIENT WAS VENTILATOR DEPENDENT. THE HOSPITAL'S BIOMEDICAL ENGINEERING DEPARTMENT INSPECTED THE MONITOR AND FOUND IT TO BE OPERATIONAL BUT ONLY THE ALARMS HAD BEEN TURNED OFF BY ICU STAFFDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.