BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M SERIES BIPHASIC

    MDR report key: 2013441 · Received March 4, 2011

    Report

    Report Number
    MW5019683
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ZOLL
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CATH LAB PROCEDURE, PATIENT REQUIRED SHOCKING, NO POWER IN DEFIBRILLATOR. DAILY CHECKS ALL OKAY AND LOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES BIPHASIC DEFIBRILLATOR MKJ ZOLL M SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening