BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 6616501 · Received June 6, 2017

    Report

    Report Number
    8030229-2017-00168
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    May 11, 2017
    Report Date
    May 11, 2017
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921114131
    PMA / PMN Number
    K102376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE LOANER CENTRAL NURSES STATION (CNS) UNIT IS RECEIVING ERROR MESSAGE "(B)(4) APPLICATION ERROR CAUGHT DRFT 271" EVERY 15 MINUTES AND WILL REBOOT WHENEVER THE CUSTOMER PRESSES OK OR CANCEL. THE LOANER UNIT WAS SENT BACK TO NIHON KOHDEN TO BE EVALUATED. THE UNIT WAS TESTED PER THE SERVICE MANUAL AND THE RESULTS WERE REPORTED ON THE MAINTENANCE CHECK SHEET. THE UNIT COMPLETED 2 HOURS OF EXTENDED TESTING AND OPERATES TO THE MANUFACTURER'S SPECIFICATIONS. THE LOANER WAS TESTED AND THE ISSUE COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE LOANER CENTRAL NURSES STATION (CNS) UNIT IS RECEIVING ERROR MESSAGE "CNS6201.EXE APPLICATION ERROR CAUGHT DRIFT 271" EVERY 15 MINUTES AND WILL REBOOT WHENEVER THE CUSTOMER PRESSES OK OR CANCEL. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LOANER CENTRAL NURSES STATION (CNS) UNIT IS RECEIVING ERROR MESSAGE "CNS6201.EXE APPLICATION ERROR CAUGHT DRIFT 271" EVERY 15 MINUTES AND WILL REBOOT WHENEVER THE CUSTOMER PRESSES OK OR CANCEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396798 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201A 04931921114131

    Patients

    Seq Age Sex Outcome Treatment
    1