BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RNS-9703-019

    MDR report key: 5052198 · Received September 2, 2015

    Report

    Report Number
    2032233-2015-00240
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 3, 2015
    Manufacturer
    NKUS LAB
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICAL SUPPORT REP AT NIHON KOHDEN LOOKED AT THE HOSPITAL'S RNS SERVER AND DID NOT SEE ANYTHING WRONG WITH THE SYSTEM AND NOTED THAT EVERYTHING WAS FUNCTIONAL. THE BIOMEDICAL ENGINEER ADVISED THE CNS WAS NOT SEEING THE BEDSIDE WAVEFORMS EITHER. THE BIOMEDICAL ENGINEER THEN DETERMINED THAT THE IP ADDRESS OF THE CNS WAS NOT LISTED ON THE HOST1000 TABLE. THE BIOMEDICAL ENGINEER ADDED THE IP ADDRESS OF THE CNS AND IT STARTED TO FUNCTION CORRECTLY. THE BIOMEDICAL ENGINEER REPORTED THAT THE RNS CLIENT STILL ONLY HAD THE PATIENT NAMES. NIHON KOHDEN'S TECHNICAL SUPPORT REP ADVISED IT COULD TAKE SOME TIME TO BUILD THE TABLE AFTER ADDING THE CNS TO THE HOST TABLE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REMOTE NETWORK STATION (RNS OR REMOTE MONITORING SYSTEM) IS SHOWING THE PATIENT NAMES BUT NOT THE WAVEFORMS OR NUMERICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581237 RNS-9703-019 RNS-9703-019 MHX NKUS LAB RNS-9703-019

    Patients

    Seq Age Sex Outcome Treatment
    1