BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL PD 1200

    MDR report key: 15989 · Received July 21, 1994

    Report

    Report Number
    15989
    Event Type
    Malfunction
    Date Received
    July 21, 1994
    Date of Event
    April 7, 1994
    Report Date
    April 11, 1994
    Manufacturer
    ZMI CORPORATION
    Product Code
    DRK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT IN MIDST OF EVOLVING ACUTE MYOCARDIAL INFARCTION AND SUBSEQUENTLY WENT INTO ATRIAL FIB WITH SLOW VENTRICULAR RESPONSE IN 30'S TO 50'S. PT. SYMPTOMATIC WITH SYSTOLIC BP DROPPING TO 60-80'S, DECREASED MENTATION AND DIAPHARESIS. PT. WAS PLACED ON DOPAMINE DRIP AND PREPARED FOR TRANSFER TO ANOTHER TERTIARY FACILITY. PD-1200 WAS GOTTEN FROM ER (HAD BEEN PLUGGED IN) AND TAKEN TO SCU ON 2ND FLOOR. PACER PATCHES AND MONITORING LEADS APPLIED TO PATIENT. PACER LEFT ON STANDBY ONLY. PT. LOADED ON AMBULANCE STRETCHER AND STARTED DOWN ELEVATOR WHEN MONITOR WENT BLANK. WE GOT TO AMBULANCE AND PLUGGED UNIT IN. IT FUNCTIONED FOR APPROXIMATELY 1 MINUTE AND IT AGAIN WENT BLANK, I TURNED IT OFF AND TURNED IT BACK ON AGAIN. IT WORKED FOR APPROXIMATELY 2-3 MINUTES WHEN IT AGAIN WENT BLANK. WE HAD TO ATTACH PT. TO AMBULANCE MONITOR/DEFIBRILLATOR TO MONITOR PT. WE NO LONGER HAD PACER ABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL PD 1200 MONITOR/DEFIBRILLATOR/PACEMAKER DRK ZMI CORPORATION PD 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other 02| TRAVENOL IV PUMP