BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-530PA

    MDR report key: 6088791 · Received November 9, 2016

    Report

    Report Number
    6088791
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    April 26, 2016
    Report Date
    September 30, 2016
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TELEMETRY BOX WAS REPORTED TO HAVE LOST SIGNAL AND WAS NOT OPERATING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739846 ZM-530PA MONITOR, CARDIAC DRT NIHON KOHDEN AMERICA, INC. ZM-530PA

    Patients

    Seq Age Sex Outcome Treatment
    1