BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 4778785 · Received May 14, 2015

    Report

    Report Number
    2080783-2015-00090
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 17, 2015
    Manufacturer
    NIHON KOHDEN CORPORATON
    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 REPORTED THAT THE CENTRAL MONITORING SYSTEM (CNS) SHOWING ALL OF THE VITAL SIGNS MONITORS GOING INTO COMMUNICATION LOSS AND FOUR OF THEIR TELEMETRY DEVICES WERE DROPPING OFF THE CNS AS WELL. MFR 8030229-2015-00090.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316597 CNS-6201 CENTRAL MONITOR SYSETM MHX NIHON KOHDEN CORPORATON CNS-6201

    Patients

    Seq Age Sex Outcome Treatment
    1 NI