BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP ELECTRODE

    MDR report key: 1082022 · Received July 21, 2008

    Report

    Report Number
    1220908-2008-01707
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Report Date
    June 30, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEFIBRILLATOR RECOGNIZED THE ADULT ELECTRODE PADS AS PEDIATRIC ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP ELECTRODE ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-0214 2408A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA