BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBEAM STE

    MDR report key: 3131489 · Received May 13, 2013

    Report

    Report Number
    2916710-2013-00010
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 13, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEM, INC.
    Product Code
    IYE
    PMA / PMN Number
    K111106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING INVESTIGATED. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT X1 JAW IS ONLY SECURED AT 1 POINT AND PIVOTING 15-20MM. NO PATIENT INVOLVEMENT WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211830 TRUEBEAM STE ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEM, INC. H19

    Patients

    Seq Age Sex Outcome Treatment
    1