BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RNS-9703-019

    MDR report key: 4901412 · Received July 7, 2015

    Report

    Report Number
    8030229-2015-00158
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 9, 2015
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WE SPOKE WITH THE CUSTOMER BIOMED, AND HE INDICATED THAT THEY PUT THEIR SPARE UNIT INTO SERVICE. THE HOSPITAL IS CONSIDERING PURCHASING A REPLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REMOTE NETWORK STATION (RNS OR REMOTE MONITORING SYSTEM) HAS FAILED AND THE UNIT WILL NOT POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440915 RNS-9703-019 MHX NIHON KOHDEN CORP. RNS-9703-019

    Patients

    Seq Age Sex Outcome Treatment
    1 NI