BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTWARE

    MDR report key: 23682 · Received July 25, 1995

    Report

    Report Number
    MW1006559
    Event Type
    Malfunction
    Date Received
    July 25, 1995
    Report Date
    July 12, 1995
    Manufacturer
    SMV
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THERE ARE NO BETA TESTING PROGRAMS ON ANY CLINICAL OR IN-HOUSE PT SOFTWARE PROGRAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTWARE SOFTWARE LNX SMV

    Patients

    Seq Age Sex Outcome Treatment
    1 *