BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1163368 · Received September 9, 2008

    Report

    Report Number
    1220908-2008-02055
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Report Date
    August 19, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 TREATING A PT THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE AND THE DEVICE WAS UNABLE TO SYNC. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION. COMPLAINANT INDICATED THAT DURING SUBSEQUENT TESTING, THE MALFUNCTION WAS NOT DUPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK