BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 4040975 · Received June 11, 2014

    Report

    Report Number
    8030229-2014-00007
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ERROR MESSAGES INDICATIVE OF A HARD DRIVE FAILURE. THE HDD WAS REPLACED AND THE UNIT WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345475 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1