BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700

    MDR report key: 4173596 · Received September 10, 2014

    Report

    Report Number
    8030229-2014-00049
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ERROR MESSAGES INDICATIVE OF A HARD DRIVE (HDD) FAILURE. DEFECTIVE DEVICE REQUESTED FOR REPAIR AND FAILURE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION. DEVICE EVALUATED BY MANUFACTURER. THE CENTRAL MONITORING SYSTEM (CNS) HAS A BLUE SCREEN, AND THERE WAS NO CAUSAL EVENT AS FAR AS THE CUSTOMER KNOWS. UPON REBOOT THE SCREEN STATES SHOWING AN "INACCESSIBLE BOOT DEVICE" MESSAGE. DEFECTIVE DEVICE REQUESTED FOR FAILURE INVESTIGATION. ERROR MESSAGES INDICATIVE OF A HARD DRIVE (HDD) FAILURE. THE UNIT WAS EVALUATED AND THE REPORTED PROBLEM WAS DUPLICATED. HARD DISK DRIVE NEEDED TO BE REPLACED. THE UNIT ALSO BOOTED UP WITH A WARNING SOUND, AND THE CPU FAN WAS RUNNING INTERMITTENTLY. THE CPU FAN WITH HEAT SINK NEEDED TO BE REPLACED FOR THAT PROBLEM. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559820 CNS-9700 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1