BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMX III

    MDR report key: 49196 · Received November 7, 1996

    Report

    Report Number
    2126677-1996-90006
    Event Type
    Other
    Date Received
    November 7, 1996
    Date of Event
    October 11, 1996
    Report Date
    November 7, 1996
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO CO THAT THE OPERATOR TRAPPED HER FINGER BETWEEN THE TUBE AND HORIZONTAL ARM DURING A PROCEDURE. APPARENTLY THIS RESULTED IN A FRACTURED FINGER. THE DEVICE WAS INSPECTED AND PLACED BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMX III DIAGNOSTIC X-RAY IZO GE MEDICAL SYSTEMS 46-134857G1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other