BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700

    MDR report key: 4850299 · Received June 15, 2015

    Report

    Report Number
    2080783-2015-00133
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    NIHON KOHDEN CORP
    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 CUSTOMER STATED THAT THE CENTRAL MONITORING SYSTEM (CNS) REBOOTED BY ITSELF. REF MFR # 8030229-2015-00133.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387532 CNS-9700 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORP CNS-9700

    Patients

    Seq Age Sex Outcome Treatment
    1 NI