Description of Event or Problem · 1
THE PATIENT, AN EIGHTY-SEVEN (87) YEAR OLD FEMALE, WAS DIAGNOSED AS HAVING COMPLETE HEART BLOCK. THE TEMPORARY NONINVASIVE PACEMAKER (ZOLL NTP MODEL NTP1000, SERIAL #1328) WAS CONNECTED IN THE EMERGENCY ROOM. THE PATIENT STABILIZED AND WAS MOVED TO THE INTENSIVE CARE UNIT, ROOM #6, AND PLACED ON ECG MONITORING (HEWLETT PACKARD CENTRAL MONITORING SYSTEM). THE PATIENT BECAME A SYSTOLE AND UPON RESPONSE BY THE NURSING STAFF, IT WAS FOUND THAT THE CONNECTOR FROM THE DISPOSABLE ELECTRODES TO THE PACER CABLE HAD BECOME DISCONNECTED. THE EVALUATION OF THE EVENT PRODUCED NO CONCLUSIVE EXPLANATION TO THE CAUSE OF THE CONNECTOR BECOMING DISCONNECTEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS, NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.