BEUDAMED
    FDA Adverse Event Summary report: N

    NCM SYSTEM

    MDR report key: 488140 · Received September 30, 2003

    Report

    Report Number
    2027454-2003-00006
    Date Received
    September 30, 2003
    Date of Event
    September 11, 2003
    Report Date
    September 11, 2003
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    HGM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMLINX NCM SOFTWARE VERISON 3.1.0. ALLOWS AUDIBLE ANNUNCIATION, INCLUDING CODE BLUE ANNUNICATION, AT MINI-MASTER STATIONS TO BE DISABLED UNINTENTIONALLY. THIS ISSUE HAS NOT BEEN REPORTED WITH OTHER SOFTWARE RELEASES. THE INFO WAS COMMUNICATED TO HILL-ROM TECHNICAL SUPPORT FROM A HILL-ROM TECHNICIAN DURING THE INSTALLATION AND CERTIFICATION OF THE PRODUCT. NO ADVERSE OUTCOME TO PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCM SYSTEM COMMUNICATIONS HGM HILL-ROM MANUFACTURING, INC. P250001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA