BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVIEWGT

    MDR report key: 2440475 · Received January 19, 2012

    Report

    Report Number
    9617016-2012-00002
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 20, 2011
    Report Date
    January 19, 2012
    Manufacturer
    ELEKTA LTD.
    Product Code
    IYE
    PMA / PMN Number
    K012289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO PTS BEING TREATED AT THE TIME THIS INTERNAL PROBLEM WAS FOUND. THE HARDWARE AND SOFTWARE HAS SINCE BEEN CHANGED, AND WE ARE AWAITING CUSTOMER FEEDBACK ON THIS ISSUE. AS SOON AS THIS IS COMPLETED, MORE DETAILS AND A CONCLUSION WILL BE PROVIDED.

    Description of Event or Problem · 1

    THERE WAS A PROBLEM AT THE CUSTOMER SITE WITH THE PT DATABASE. THE REFERENCE IMAGE WOULD DISAPPEAR, AND AT TIMES AN IVIEWGT IMAGE WOULD ALSO DISAPPEAR. IT WAS ALSO FOUND THAT THE IMAGE TAKEN FOR ONE PT WOLD BE AFFECTED TO ANOTHER PT IN THE IVIEWGT DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVIEWGT ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LTD. R3.2/WINDOWSNT

    Patients

    Seq Age Sex Outcome Treatment
    1