BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 4949344 · Received July 27, 2015

    Report

    Report Number
    2080783-2015-00182
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 29, 2015
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CENTRAL MONITORING SYSTEM (CNS) ARE SHOWING TEMPORARY COMMUNICATION LOSS AND THE DEVICES WOULD LOSE COMMUNICATION AND THEN COME BACK UP AND OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485552 CNS-6201 MHX NIHON KOHDEN CORP. CNS-6201

    Patients

    Seq Age Sex Outcome Treatment
    1 NI