BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE DESKTOP PRO

    MDR report key: 1702505 · Received May 18, 2010

    Report

    Report Number
    9617016-2010-00003
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    April 21, 2010
    Report Date
    May 18, 2010
    Manufacturer
    ELEKTA LTD.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL DETECTION. 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

    FAILURE TO RAISE RESET KEY INHIBIT FOLLOWING FAILURE OF TERMINATION CHECKS. THE "RESET KEY" INHIBIT IS INTENDED TO IDENTIFY TO THE USER THAT AN INTERLOCKS CAPABILITY TO TERMINATE RADIATION HAS BEEN LOST. THE PROBLEM WAS FOUND DURING THE INVESTIGATION OF ANOTHER ISSUE. (B)(6) ENGINEERS FOUND THAT IF THE CHECKS THAT RUN DURING 'TERMINATED CHECKING' FAIL, THEN THE RESET KEY INHIBIT WILL NOT BE RAISED AS EXPECTED, IF THE SYSTEM IS BEING USED WITH MOSAIQ R&V SYSTEM.

    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