BEUDAMED
    FDA Adverse Event Summary report: N

    CNS-6201

    MDR report key: 3952041 · Received June 18, 2014

    Report

    Report Number
    2080783-2014-00010
    Date Received
    June 18, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CENTRAL MONITORING SYSTEM (CNS) WENT DOWN AND WOULD NOT REBOOT. (B)(6) ON CALL TECHNICIAN HAD CUSTOMER REMOVE ONE HDD AND ATTEMPT RESTART. SYSTEM CAME UP BUT HAS ONE BAD HDD. REF # MFR 8030229-2014-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358770 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6201

    Patients

    Seq Age Sex Outcome Treatment
    1 NI