BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 4198600 · Received October 6, 2014

    Report

    Report Number
    2080783-2014-00061
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CENTRAL MONITORING SYSTEM (CNS) FROZE UP, NO VITAL SIGN OR WAVEFORMS ARE MOVING. MOUSE AND KEYBOARD ARE UNRESPONSIVE. CUSTOMER POWERED UNIT OFF AND IT WILL NOT BOOT TO THE OS OR CNS SOFTWARE APPLICATION. REFERENCE MFR # 8030229-2014-00061.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622734 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN AMERICA, INC. CNS-6201

    Patients

    Seq Age Sex Outcome Treatment
    1 NI