BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE DESKTOP PRO

    MDR report key: 1694049 · Received May 7, 2010

    Report

    Report Number
    9617016-2010-00001
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    March 17, 2010
    Report Date
    May 4, 2010
    Manufacturer
    ELEKTA, LTD
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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

    CUSTOMER HAS REPORTED THAT THE LINAC IN CLINICAL MODE WITH MOSIAQ THAT THEY HAVE NOTICED A DOSEMETRY DISCREPANCY. THEY WERE ALERTED TO THE PROBLEM WHEN MOSIAQ REPORTED AN OVER DOSE OF 0.1. WHEN THEY LOOKED AT WHAT THE LINAC HAD DELIVERED, THEY NOTICED THAT BEAM MU 1 HAD DELIVERED WHAT WAS EXPECT, BUT THE BACKUP MU WAS HALF OF WHAT IT IS SHOULD BE AND THE LCD BACKUP DISPLAY AGREED WITH THE BACKUP MU WHICH IS HALF OF BEAM MU 1, THIS HAS BEEN IDENTIFIED ON A NUMBER OF PTS ON THE SAME DAY. THE ISSUE WAS RESOLVED BY REBOOTING THE MACHINE.

    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