BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-9700

    MDR report key: 4384936 · Received December 24, 2014

    Report

    Report Number
    2080783-2014-00173
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    July 12, 2012
    Report Date
    July 12, 2012
    Manufacturer
    NIHON KOHDEN CORP
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CENTRAL MONITORING SYSTEM (CNS) CRASHED AND THE CUSTOMER HAS CONFIRMED THAT THE HDD HAS FAILED. UNIT WILL NOT BOOT UP. REF MFR #: 8030229-2014-000173.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850224 CNS-9700 CENTRAL MONITOR SYS MHX NIHON KOHDEN CORP CNS-9700

    Patients

    Seq Age Sex Outcome Treatment
    1 NI