BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL

    MDR report key: 2132672 · Received February 9, 2008

    Report

    Report Number
    MW5020993
    Event Type
    Injury
    Date Received
    February 9, 2008
    Date of Event
    November 28, 2007
    Report Date
    November 29, 2007
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CODE INVOLVING A PT WITH IACD. PT HAD SHOCKABLE RHYTHM AND IACD DID NOT CONVERT ARRHYTHMIA. ZOLL M SERIES WITH SERIAL NUMBER ENTERED ON THIS FORM WAS USED TO DELIVER 200J W/PADDLES. AMOUNT OF J DELIVERED WAS LESS THAN 40J. FOUR MINUTES LATER, DEFIBRILLATOR USED TO DELIVER 200J AND LESS THAN 40 J WAS AGAIN DELIVERED. UNIT WAS TESTED THE DAY OF EVENT BOTH PRIOR TO AND FOLLOWING THE EVENT AND PASSED TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening