BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RNS-9703-024

    MDR report key: 6013331 · Received October 9, 2016

    Report

    Report Number
    2032233-2016-00509
    Event Type
    Malfunction
    Date Received
    October 9, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 9, 2016
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: THE CUSTOMER REPORTED THAT THE RNS (REMOTE NETWORK STATION) KEPT EXITING THE MONITORING SOFTWARE ON ITS OWN, GIVING A "CNS- (B)(4).EXE" APPLICATION ERROR. THE BIOMED TRIED RESTARTING THE DEVICE AND TRIED DIFFERENT NETWORK CONNECTIONS, HOWEVER THE ISSUE PERSISTED. THE DEVICE WAS EVALUATED AND THE PROBLEM WAS DUPLICATED. THE CUSTOMER WAS SENT AN EXCHANGE UNIT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE RNS (REMOTE NETWORK STATION) KEPT EXITING THE MONITORING SOFTWARE ON ITS OWN, GIVING A "CNS-6201.EXE" APPLICATION ERROR. THE BIOMED TRIED RESTARTING THE DEVICE AND TRIED DIFFERENT NETWORK CONNECTIONS, HOWEVER THE ISSUE PERSISTED. THE CUSTOMER WILL RETURN THE DEVICE FOR EVALUATION AND RECEIVED AN EXCHANGED DEVICE. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RNS (REMOTE NETWORK STATION) KEPT EXITING THE MONITORING SOFTWARE ON ITS OWN, GIVING A "CNS-6201.EXE" APPLICATION ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664706 RNS-9703-024 REMOTE NETWORK STATION MHX NIHON KOHDEN CORPORATION RNS-9703-024

    Patients

    Seq Age Sex Outcome Treatment
    1