BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RNS-9703-19

    MDR report key: 4777902 · Received May 14, 2015

    Report

    Report Number
    8030229-2015-00089
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 16, 2015
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Removal / Correction Number
    2080783-04-15/15-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING REQUESTED DEVICE FOR REPAIR AND FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REMOTE NETWORK STATION (RNS OR REMOTE MONITORING SYSTEM) HAD VOLUME LOSS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316430 RNS-9703-19 REMOTE NETWORK STATION MHX NIHON KOHDEN CORP. RNS-9703-019

    Patients

    Seq Age Sex Outcome Treatment
    1 NI