BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 3952081 · Received June 18, 2014

    Report

    Report Number
    2080783-2014-00012
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CENTRAL MONITORING SYSTEM (CNS) SCREEN FROZE AND WILL NOT BOOTUP. BIOMEDICAL ENGINEER STATES THAT THE CNS HAD A HARD DRIVE (HDD) FAILURE. REF # MFR 8030229-2014-00012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358231 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other