BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 4173616 · Received September 10, 2014

    Report

    Report Number
    2080783-2014-00046
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    NIHON KOHDEN CORP
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CENTRAL MONITORING SYSTEM (CNS) JUST RECENTLY HAD A HARD DISK DRIVE REPLACEMENT. THE CUSTOMER IS STATING THE UNIT PERIODICALLY FREEZES UP A FEW TIMES A DAY. WHEN THE CNS FREEZES, ALL NUMERICS AND WAVEFORMS STOP. A HARD POWER CYCLE IS REQUIRED FOR THE UNITS TO MONITOR THE BEDS AGAIN. MFR REF#: 8030229-2014-00046.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559736 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORP CNS-6201

    Patients

    Seq Age Sex Outcome Treatment
    1 NI