BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RNS-9703-024

    MDR report key: 4870830 · Received June 24, 2015

    Report

    Report Number
    8030229-2015-00147
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CHECKED THE NETWORK CLOSET AND EVERYTHING APPEARS TO BE FINE. WE FOLLOWED UP WITH THE CUSTOMER, AND THEY STATED THAT RNS SERVER CAME BACK UP AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REMOTE NETWORK STATIONS (RNS OR REMOTE MONITORING SYSTEM) ARE EXPERIENCING COMMUNICATION LOSS ON ALL DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410408 RNS-9703-024 REMOTE NETWORK STATION MHX NIHON KOHDEN CORPORATION RNS-9703-024

    Patients

    Seq Age Sex Outcome Treatment
    1 NI