BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL MEDICAL CORP

    MDR report key: 510917 · Received February 2, 2004

    Report

    Report Number
    MW1031048
    Event Type
    Malfunction
    Date Received
    February 2, 2004
    Date of Event
    January 9, 2004
    Report Date
    January 12, 2004
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A CODE IN ICU PT WAS DEFIBRILLATED TWICE WITH ZOLL BI-PHASIC DEFIBRILLATOR. ON THIRD ATTEMPT UNIT DID NOT WORK. FAILURE OF UNIT DID NOT EFFECT RESUSCITATION OF PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other