BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINGAR COLLIMATOR

    MDR report key: 889514 · Received July 2, 2007

    Report

    Report Number
    889514
    Event Type
    Malfunction
    Date Received
    July 2, 2007
    Date of Event
    June 25, 2007
    Report Date
    July 2, 2007
    Manufacturer
    PROGENY, INC
    Product Code
    IZW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCREW LOOSE IN THE RADIATION FIELD LEAVING ARTIFACT ON IMAGES. SERVICE CALLED. DEVICE CHECKED AND CLEANED. COULD NOT FIND WHERE SCREW CAME FROM IN HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINGAR COLLIMATOR X-RAY SYSTEM COLLIMATOR IZW PROGENY, INC * 70-75002

    Patients

    Seq Age Sex Outcome Treatment
    1 *