BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORAD MIV

    MDR report key: 240654 · Received September 14, 1999

    Report

    Report Number
    240654
    Event Type
    Injury
    Date Received
    September 14, 1999
    Date of Event
    September 7, 1999
    Report Date
    September 10, 1999
    Manufacturer
    TREX MEDICAL CORP.
    Product Code
    IZH
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN RADIOLOGY FOR BREAST LOCALIZATION PRIOR TO SURGERY. INITIAL FILMS TAKEN, PROCEEDED TO MOVE PT ON THE CHAIR OUT OF THE WAY OF THE MACHINE (MAMMOGRAPHY UNIT). MOVED CHAIR WHEEL CAUGHT ON THE FOOT PEDAL THAT MOVES TUBE HEAD UP AND DOWN CAUSING MACHINE TO LOWER ONTO PTS' THIGH. EMERGENCY SHUT DOWN SWITCH ACTIVATED WITH NO RELEASE OF PRESSURE TO LEG (THIGH). TURNED MACHINE ON AND WAS ABLE TO RELEASE THE PT FROM UNDER THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LORAD MIV MAMMOGRAPHY UNIT IZH TREX MEDICAL CORP. 40000029 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization