BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700

    MDR report key: 4939530 · Received July 22, 2015

    Report

    Report Number
    2080783-2015-00178
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 24, 2015
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CENTRAL MONITORING SYSTEM (CMB) LOST SOME WAVEFORMS AND PARAMETERS AFTER INSTALLING A NEW VITAL SIGNS MONITOR. THEY STOPPED MONITORING THE NEW VITAL SIGNS MONITOR ON THE CNS AND EVERYTHING WAS BACK TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476795 CNS-9700 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-9700

    Patients

    Seq Age Sex Outcome Treatment
    1 NI