BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE DESKTOP PRO

    MDR report key: 1694899 · Received May 14, 2010

    Report

    Report Number
    9617016-2010-00002
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    April 26, 2010
    Report Date
    May 14, 2010
    Manufacturer
    ELEKTA LTD.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS SITUATION IS ONGOING AT THIS TIME. ONCE THE INVESTIGATION IS COMPLETED, MORE DETAILS AND A CONCLUSION WILL BE PROVIDED.

    Description of Event or Problem · 1

    WHEN A PT IS LOADED FROM MOSAIQ SOFTWARE AND TREATED NORMALLY WITH XXX MU, AFTER TREATMENT IS FINISHED, THE DETAILS ARE SENT TO MOSAIQ USING ICOM. DURING THE TRANSMISSION OF DETAILS FROM DESKTOP PRO TO MOSAIQ, IF ANOTHER PT IS SELECTED ON THE XVI SYS, THIS XVI INFO IS PRIORITIZED AND THE DATA FROM THE END OF THE TREATMENT IS NEVER REC'D BY MOSAIQ. IF THIS HAPPENS, AS MOSAIQ HAS NOT BEEN ABLE TO RECORD THE TREATMENT, IT PRESENTS THE CLINICAL USER WITH THE FOLLOWING WARNING DIALOGUE: "MU DELIVERED IS LESS THAN EXPECTED, XXX MU REMAINING, DELIVER REMAINDER?" IF THE USER SELECTS 'YES' THEN MOSAIQ WILL DOWNLOAD THE REMAINING MU, (WHICH IT CALCULATES INCORRECTLY AS THE TOTAL FIELD MU OF THE PREVIOUSLY DELIVERED FIELD), ALLOWING AN IMMEDIATE RETREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE DESKTOP PRO DESKTOP PRO IYE ELEKTA LTD. ALL

    Patients

    Seq Age Sex Outcome Treatment
    1