BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 1830425 · Received September 2, 2010

    Report

    Report Number
    1220908-2010-02535
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Report Date
    August 13, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MED CORP 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 WHILE ATTEMPTING TO MONITOR THE HEART RHYTHM OF A PT, THE DEVICE WAS UNABLE TO OBTAIN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R SERIES DEFIBRILLATOR R SERIES MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK