BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700

    MDR report key: 4040989 · Received June 11, 2014

    Report

    Report Number
    8030229-2014-00008
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CNS NOT BOOTING TO NK SOFTWARE AND THEN BOOTS AND HAS A BLACK SCREEN WHICH IS SUGGESTIVE OF A HARD DRIVE FAILURE. HOWEVER, UPON RECEIVING THE UNIT, SERVICE COULD NOT DUPLICATE THE ISSUE. CUSTOMER UNIT WAS INSTALLED IN 2007 AND TO THE BEST OF THE CUSTOMER'S KNOWLEDGE THE HARD DRIVE HAS NEVER BEEN REPLACED. INFORMED CUSTOMER OF THE RECOMMENDED 2 YEAR HARD DRIVE REPLACEMENT INTERVAL - WAITING FOR CUSTOMER RESPONSE TO REPLACE OR NOT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS RETURNED AND EVALUATED. THE ISSUE COULD NOT BE DUPLICATED. THE UNIT WAS TESTED AND BURNED FOR SEVERAL DAYS. THE UNIT BOOTED UP TO THE PATIENT MONITORING SCREEN EVERY TIME. THE UNIT NEVER BOOTED UP TO A BLACK SCREEN. CUSTOMER REQUESTED THAT THE HARD DRIVE BE CHANGED. THE HARD DRIVE WAS CHANGED AND THE SETTINGS WERE RESTORED. ALL FUNCTIONS WERE TESTED PRIOR TO SHIPPING THIS UNIT BACK TO THE CUSTOMER.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345720 CNS-9700 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1