BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700

    MDR report key: 4040977 · Received June 11, 2014

    Report

    Report Number
    8030229-2014-00005
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BLUE SCREEN VISIBLE AND THE CNS NOT BOOTING TO WINDOWS OS - INDICATIVE OF A HARD DRIVE FAILURE. CUSTOMER WAS ADVISED ON APPROPRIATE REPLACEMENT PARTS.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345710 CNS-9700 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1