BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201A

    MDR report key: 5965601 · Received September 21, 2016

    Report

    Report Number
    8030229-2016-00474
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    May 23, 2016
    Report Date
    May 23, 2016
    Manufacturer
    NIHON KOHDEN TOMIOKA CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE TOUCH SCREEN TO THE CNS (CENTRAL NURSE'S STATION) HAS NO BACK LIGHT. THE CUSTOMER RETURNED THE TOUCHSCREEN PART NUMBER: A/E000528, SERIAL NUMBER: (B)(4) TO NIHON KOHDEN. THE TOUCHSCREEN WAS EVALUATED AND FOUND TO BE WORKING FINE, HOWEVER THE POWER SUPPLY TO THE TOUCHSCREEN WAS FOUND TO BE THE ROOT CAUSE. ALL STEPS ON THE MAINTENANCE CHECK SHEET OF THE SERVICE MANUAL WERE COMPLETED AND AN EXTENDED TEST FOR A DAY WAS PERFORMED. NIHON KOHDEN HAD PROVIDED THE CUSTOMER WITH A REPLACEMENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TOUCH SCREEN TO THE CNS (CENTRAL NURSE'S STATION) HAS NO BACK LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618441 CNS-6201A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN TOMIOKA CORPORATION CNS-6201A

    Patients

    Seq Age Sex Outcome Treatment
    1