BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO

    MDR report key: 5906689 · Received August 26, 2016

    Report

    Report Number
    1937649-2016-00006
    Event Type
    Malfunction
    Date Received
    August 26, 2016
    Report Date
    December 1, 2017
    Manufacturer
    ELEKTA INC
    Product Code
    MUJ
    PMA / PMN Number
    K102216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 1

    SECTIONS HAVE BEEN UPDATED AS IMPAC MEDICAL SYSTEMS INC HAS CHANGED ITS NAME TO ELEKTA INC AS OF THE (B)(6) 2017. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT, HOWEVER AS LONG AS CLINICAL QA CHECKS ARE CARRIED OUT THIS ISSUE CAN BE DETECTED, REDUCING THE PROBABILITY OF THIS OCCURRING TO IMPLAUSIBLE . THIS DEFECT HAS BEEN FIXED IN THE FOLLOWING RELEASE OF XIO VERSION 5.10.03.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER IS ABLE TO (B)(6) EXPORT IMRT PLANS THAT HAVE ONLY BEEN OPTIMIZED AND NOT SEGMENTED. THE CUSTOMER COULD DELIVER THE PLAN. THERE WAS NO MISTREATMENT REPORTED BASED ON THE AVAILABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557689 XIO SYSTEM, PLANNING, RADIATION THERAPY TREATMENT, PRODUCT MUJ ELEKTA INC

    Patients

    Seq Age Sex Outcome Treatment
    1