BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECG ELECTRODES

    MDR report key: 3446933 · Received September 23, 2013

    Report

    Report Number
    1220908-2013-02696
    Event Type
    Malfunction
    Date Received
    September 23, 2013
    Date of Event
    July 25, 2013
    Report Date
    September 5, 2013
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT 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 ATTEMPTING TO TREAT A PATIENT A WIRE SEPARATED FROM THE ELECTRODE PAD. COMPLAINANT DID NOT INDICATE THAT THERE WAS NAY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479776 ECG ELECTRODES ECG ELECTRODES MKJ ZOLL MEDICAL CORPORATION 8900-0003 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK