BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RNS-9703-024

    MDR report key: 5176296 · Received October 25, 2015

    Report

    Report Number
    2032233-2015-00327
    Event Type
    Malfunction
    Date Received
    October 25, 2015
    Date of Event
    September 25, 2015
    Report Date
    September 25, 2015
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE RNS (REMOTE NETWORK SYSTEM OR REMOTE MONITORING SYSTEM) IS CRASHING WITH ERROR CODE "THE MEMORY COULD NOT BE READ" BY CNS6201.EXE. THE BIOMEDICAL ENGINEER ATTEMPTED TO REBOOT THE MACHINE WHICH STARTS THE PROGRAM AGAIN BUT THEN IT CRASHED AGAIN. THE DEVICE WAS EVALUATED AND THE REPORTED PROBLEM WAS DUPLICATED. THE CUSTOMER IDENTIFIED THE CAUSE OF THE MALFUNCTION. A REPLACEMENT MODULE OR COMPONENT WAS SENT TO THE CUSTOMER. BASED ON THE INFORMATION PROVIDED AT THE TIME OF THE EVENT ASSESSMENT, THERE IS NO INDICATION THAT WAS A PATIENT INJURY OR A REPORTABLE EVENT AS A RESULT OF THIS ISSUE. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RNS (REMOTE NETWORK SYSTEM OR REMOTE MONITORING SYSTEM) IS CRASHING WITH ERROR CODE "THE MEMORY COULD NOT BE READ" BY CNS6201.EXE. THE BIOMEDICAL ENGINEER ATTEMPTED TO REBOOT THE MACHINE WHICH STARTS THE PROGRAM AGAIN BUT THEN IT CRASHED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707094 RNS-9703-024 REMOTE NETWORK STATION MHX NIHON KOHDEN CORPORATION RNS-9703-024

    Patients

    Seq Age Sex Outcome Treatment
    1