BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOIL PACEMAKER/DEFIBRILLATOR

    MDR report key: 4346 · Received July 2, 1992

    Report

    Report Number
    4346
    Event Type
    Malfunction
    Date Received
    July 2, 1992
    Date of Event
    May 25, 1992
    Manufacturer
    ZMI CORPORATION
    Product Code
    DRO
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ZOLL EXTERNAL PACEMAKER WAS ATTACHED TO PATIENT AND STOPPED PACING AFTER APPROXIMATELY 45 MINUTES. UNIT WAS OPERATING FROM AC POWER; HOWEVER, DISPLAY INDICATED "HOW BATTERY". AC OUTLET CHECKED AND VERIFIED PRESENCE OF AC POWER. UNIT WAS CONTINUED TO USE TO PACE PATIENT BY CONTINUALLY SWITCHING PACER SWITCH OFF AND THEN BACK ON. UNIT WAS USED UNTIL MEDICAL TRANSPORT TEAM ARRIVED. FACTORY SERVICE WAS CALLED-INDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUL-91. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. 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, INVALID DATA. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILED JUST PRIOR TO USE, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOIL PACEMAKER/DEFIBRILLATOR PACEMAKER/DEFIBRILLATOR DRO ZMI CORPORATION PD 1200 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other