BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 3952130 · Received June 18, 2014

    Report

    Report Number
    8030229-2014-00011
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO REPRODUCE THE PROBLEM. PERFORMED A HARD SHUTDOWN OF THE CNS AND RESTARTED. NIHON KOHDEN ON CALL TECH SUPPORT VERIFIED THE CNS STARTED WITH NO ISSUE, VERIFIED THERE WAS NO RAID HARD DRIVE ERRORS, THE NK APPLICATION STARTED AND WAS OPERATING AS NORMAL.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358388 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1