BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700

    MDR report key: 3952677 · Received July 11, 2014

    Report

    Report Number
    2080783-2014-00024
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 22, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CENTRAL MONITORING SYSTEM CNS WILL NOT OPEN APPLICATION. ATTEMPTED RESTARTING THE CNS BUT THE ISSUE REMAINS. MFR - 8030229-2014-00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407567 CNS-9700 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-9700

    Patients

    Seq Age Sex Outcome Treatment
    1 NI