BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RNS-9703-19

    MDR report key: 4756649 · Received May 5, 2015

    Report

    Report Number
    8030229-2015-00075
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    April 7, 2015
    Report Date
    April 7, 2015
    Manufacturer
    NIHON KOHDEN CORP
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REMOTE NETWORK STATION (RNS OR REMOTE MONITORING SYSTEM) WILL OCCASIONALLY BE FOUND POWERED ON WITH A GREY SCREEN. THE CUSTOMER CAN RESTART THE UNIT TO RESOLVE THE ISSUE BUT THEN FINDS IT YET AGAIN WITH A GREY SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295348 RNS-9703-19 REMOTE NETWORK STATION MHX NIHON KOHDEN CORP RNS-9703-019

    Patients

    Seq Age Sex Outcome Treatment
    1 NI