BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL MEDICAL CORPORATION

    MDR report key: 6773122 · Received August 4, 2017

    Report

    Report Number
    MW5071409
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    July 28, 2017
    Report Date
    August 4, 2017
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    UDI-DI
    00847946016272
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE ADULT DEFIBRILLATOR ELECTRODES WERE INCORRECTLY RECOGNIZED AS PEDIATRIC ELECTRODES WHEN CONNECTED TO ZOLL DEFIBRILLATOR. FEW OTHER ELECTRODES OF THE SAME LOT # 2517A WERE CHECKED AND THEY HAD THE SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546489 ZOLL MEDICAL CORPORATION DEFIBRILLATOR ADULT PADS MKJ ZOLL MEDICAL CORP. ONESTEP CPA 2517A 00847946016272

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR