BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700

    MDR report key: 4143662 · Received August 12, 2014

    Report

    Report Number
    8030229-2014-00040
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOANER HAS BEEN SENT TO THE CUSTOMER AND RETURN OF DEFECTIVE DEVICE REQUESTED FOR FAILURE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DEVICE AVAILABLE FOR EVALUATION, DEVICE EVALUATED BY MANUFACTURER, MANUFACTURER NARRATIVE. MANUFACTURER NARRATIVE: THE CENTRAL MONITORING SYSTEM (CNS)SCREEN WENT BLACK. THE CUSTOMER TRIED TO POWER CYCLE THE UNIT BY PRESSING THE POWER BUTTON BUT THE UNIT WOULD NOT REBOOT. CUSTOMER REPLACED THE HARD DRIVE BUT THE ISSUE REMAINS. THE UNIT WAS EVALUATED AND THE CUSTOMER' S COMPLAINT WAS DUPLICATED. THE MOTHER BOARD WAS REPLACED TO RESOLVE THE ISSUE. ALL FUNCTIONS WERE TESTED PRIOR TO SHIPPING. 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
    479696 CNS-9700 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-9700

    Patients

    Seq Age Sex Outcome Treatment
    1