BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPR STAT PADZ

    MDR report key: 3190077 · Received June 7, 2013

    Report

    Report Number
    1220908-2013-01424
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT, AN ARC WAS SEEN FROM THE ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254136 CPR STAT PADZ ELECTRODE MKJ ZOLL MEDICAL CORPORATION 8900-0400 4712

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK