BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 2221816 · Received August 18, 2011

    Report

    Report Number
    2221816
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    AMBULANCE CREW RESPONDED TO MALE FOUND ON THE FLOOR AT HOME WITH CPR IN PROGRESS. THE CREW CONNECTED THE PATIENT TO THE PORTABLE MONITOR/DEFIBRILLATOR. THE MONITOR DISPLAYED: VENTRICULAR FIBRILLATION. THE DEFIBRILLATOR WAS CHARGED TO 200 JOULES. THE DEFIBRILLATOR SOUNDS; READY TO DELIVER SHOCK. SHOCK BUTTON PRESSED. MONITOR SCREEN GOES BLANK, NO SHOCK DELIVERED. THE PATIENT WAS TAKEN OUT TO AMBULANCE. THE MONITOR WAS PLUGGED INTO AC (ELECTRICAL) OUTLET. MONITOR TURNED ON. THE MONITOR DISPLAYS VENTRICULAR FIBRILLATION. THE DEFIBRILLATOR WAS CHARGED TO 200 JOULES. SHOCK BUTTON PRESSED. THE SHOCK IS DELIVERED. THE AMBULANCE CREW FELT THE BATTERY FOR THE MONITOR WAS HOLDING THE CHARGE AND PLACED THE BATTERY ON A CHARGER. THE DEFIBRILLATOR WAS RETURNED TO THE AMBULANCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR