BEUDAMED
    FDA Adverse Event Summary report: N

    M SERIES CCT

    MDR report key: 2112254 · Received May 26, 2011

    Report

    Report Number
    2112254
    Date Received
    May 26, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A VENTRICULAR RHYTHM, ATTEMPTED TO DEFIBRILLATE. UNSUCCESSFUL ATTEMPT TO CHARGE THE ZOLL MONITOR DEFIBRILLATOR. THE RN INVOLVED CHECKED THE CONNECTIONS OF PADS (ELECTRODES) TO THE MACHINE, ALL CONNECTED. LOOKED AT THE MONITOR DEFIBRILLATOR KNOB POSITION. THE POSITION WAS IN THE MIDDLE BETWEEN MONITOR AND DEFIBRILLATOR MODE. THE DEVICE WAS NOT ENGAGED IN DEFIBRILLATOR MODE. RN IMMEDIATELY TURNED THE MONITOR OFF AND BACK TO DEFIBRILLATOR MODE AND WAS ABLE TO CHARGE TO 200 JOULES AND DEFIBRILLATE THE PATIENT. THE MONITOR DEFIBRILLATOR WAS LEFT IN THIS MODE THROUGHOUT THE CASE FOR SEVERAL OTHER DELIVERIES OF SHOCKS.MANUFACTURER RESPONSE FOR EXTERNAL DEFIBRILLATOR, M SERIES, CCT: AT THIS TIME, NO RESPONSE; STILL UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES CCT EXTERNAL DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION M SERIES CCT *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR CARDIAC DRUGS