BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISEPLAN

    MDR report key: 934703 · Received April 12, 2007

    Report

    Report Number
    9617016-2007-00017
    Event Type
    Malfunction
    Date Received
    April 12, 2007
    Date of Event
    March 21, 2007
    Report Date
    April 12, 2007
    Manufacturer
    ELEKTA LTD.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS NOT BEING USED ON A PT AT THE TIME OF USE, THEREFORE, THERE WAS NO PT INJURY. INVESTIGATION IS CURRENTLY TAKING PLACE. ONCE THE INVESTIGATION IS COMPLETED A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    WHEN EXPORTING A DRR, THE CENTER OF THE IMAGE IS DIFFERENT FROM THE CENTER OF THE DRR IN PRECISEPLAN (UP TO 3MM). THIS IS APPLICABLE TO VERSION 2.03 AND 2.11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISEPLAN NONE IYE ELEKTA LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *