BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700

    MDR report key: 5005245 · Received August 12, 2015

    Report

    Report Number
    2080783-2015-00211
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CENTRAL MONITORING SYSTEM (CNS) TURNED OFF BY ITSELF AND WILL NOT POWER BACK ON. REFERENCE MFR # 8030229-2015-00211.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528746 CNS-9700 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN AMERICA, INC. CNS-9700

    Patients

    Seq Age Sex Outcome Treatment
    1 NI