BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 364485 · Received December 4, 2001

    Report

    Report Number
    1220908-2001-01653
    Event Type
    Death
    Date Received
    December 4, 2001
    Report Date
    November 6, 2001
    Manufacturer
    ZOLL M EDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE MEDICS RESPONDED TO A CALL FOR PATIENT WHO WAS IN CARDIAC ARREST DUE TO A DROWNING IN A SWIMMING POOL. UPON THE MEDICS' ARRIVAL, THE PATIENT WAS FOUND WET AND LYING BESIDE THE POOL "WITH NO SIGNS OF LIFE." THE MEDICS DRIED THE PATIENT AND APPLIED MULTI-FUNCTION ELECTRODES TO THE PATIENT. THE MEDICS THEN ATTEMPTED TO ANALYZE THE PATIENT'S HEART RHYTHM WITH THE DEIVCE IN AED MODE, BUT THE DEVICE FAILED TO DISPLAY THE PATIENT'S HEART RHYTHM. THE MEDICS THEN SWITCHED THE DEVICE TO MANUAL MODE, BUT THE UNIT STILL WOULD NOT DISPLAY THE PATIENT'S HEART RHYTHM. THE MEDICS THEN PERFORMED PATIENT CRP. THE MEDICS THEN OBTAINED A SECOND DEVICE AND MONITORED THE PATIENT'S HEART RHYTHM. THE PATIENT SUBSEQUENTLY EXPIRED, BUT THE COMPLAINANT INDICATED THAT THE PATIENT OUTCOME WAS NOT AS A RESULT OF THE REPORTED MALFUNCTION. SUBSEQUENT TO THE EVENT, THE DEVICE WAS RETURNED TO THE STATION AND TESTED. DURING THIS TESTING, THE MEDIC PRESSED THE MONITOR BUTTON, AND THE DEIVCE SWITCHED TO MANUAL MODE, WITHOUT THE CONFIRM BUTTON BEING DEPRESSED, IN ADDITION, WHEN THE MEDIC ADJUSTED THE ENERGY SETTING, THE DEVICE BEGAN TO CHARGE, ALTHOUGH IT DID NOT DISCHARGE THE ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54485 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL M EDICAL CORPORATION MSERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death