BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 3908477 · Received June 3, 2014

    Report

    Report Number
    8030229-2014-00004
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REBOOT ERROR MESSAGE ON SCREEN INDICATING "HARD DISK "0" DEGRATING." LOANER CNS WAS SENT TO CUSTOMER TO USE DURING THE PERIOD THEY RETURNED THE UNIT FOR REPAIR AND UNTIL THEY RECEIVED THE REPAIRED UNIT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER. ADDITIONAL MANUFACTURER NARRATIVE: DEVICE WAS RETURNED AND EVALUATED. CUSTOMER COMPLAINT WAS DUPLICATED. BOTH HARD DRIVES WERE REPLACED AND RECONFIGURED. THE UNIT WAS TESTED AND ALL STEPS IN THE MAINTENANCE CHECK SHEET WERE COMPLETED PER THE SERVICE MANUAL. THE REPAIRED DEVICE WAS SHIPPED BACK TO THE CUSTOMER.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324371 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1