BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 4143678 · Received August 12, 2014

    Report

    Report Number
    8030229-2014-00036
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAD CUSTOMER RESTART THE CNS AND CONFIRMED FULL OPERATION OF CNS WAS RESTORED. ALL PT MONITORING RESUMED. ADVISED BME TO HAVE STAFF MONITOR THE SYSTEM FOR FUTURE ERRORS.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479989 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1