BEUDAMED
    FDA Adverse Event Other Summary report: N

    LORAD HOLOGIC SELENIA

    MDR report key: 841993 · Received April 19, 2007

    Report

    Report Number
    MW1042658
    Event Type
    Other
    Date Received
    April 19, 2007
    Date of Event
    April 19, 2007
    Report Date
    April 19, 2007
    Manufacturer
    *
    Product Code
    IZH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING COMPRESSION ON MAMMOGRAPHY, PATIENT APPEARS TO HAVE INADVERTENTLY HANDLED CONTROL BUTTONS LOCATED IN THE BACK OF UNIT, CAUSING C-ARM TO RAISE WHILE CONTINUING COMPRESSION. TECHNOLOGIST WAS UNABLE TO RELEASE COMPRESSION WITH FOOT PEDALS. UNIT RELEASED COMPRESSION AFTER A FEW SECONDS. FIELD ENGINEER CAME IN WITHIN THE HOUR, CHECKED ALL SWITCHES AND FOUND THAT IF 12 LBS OR LESS OF FORCE IS USED, THE PT COULD INDEED MOVE THE C-ARM. THE FIELD ENGINEER COULD NOT REPLICATE THE FAILURE OF THE FOOT PEDAL TO RELEASE COMPRESSION. SHE ORDERED REPLACEMENT FOOT PEDALS DESPITE THE PRESENT ONES TESTING OUT OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LORAD HOLOGIC SELENIA * IZH * SELENIA *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other