BEUDAMED
    FDA Adverse Event Summary report: N

    XVI

    MDR report key: 3181285 · Received June 21, 2013

    Report

    Report Number
    9617016-2013-00011
    Date Received
    June 21, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    PMA / PMN Number
    K100115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS INCIDENT IS ON-GOING AT THIS TIME. ONCE THE INVESTIGATION IS COMPLETE, ELEKTA WILL FORWARD ADDITIONAL INFORMATION TO THE FDA.

    Additional Manufacturer Narrative · 1

    IN THIS INSTANCE THE QA PROCEDURES WERE NOT REGULARLY FOLLOWED AT THE HOSPITAL, WHICH ARE IN PLACE TO DETECT DRIFTS AND VARIATIONS. IN THIS CASE ONE COMPONENT WAS THE CAUSE AND THAT SHOULD NOT HAVE GONE UNNOTICED. THE COARSE AND FINE POTS WERE REPLACED AND THE TABLE WAS RE-CALIBRATED. NO FURTHER ACTION IS PLANNED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A 3MM ERROR IN XVI REGISTRATION. THE RELATIVE AUTOMATIC TABLE MOVE (RATM) DID NOT MOVE TO THE CORRECT POSITION, POSSIBLY DUE TO AN ISSUE WITH THE FINE POTENTIOMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282492 XVI DIGITAL IMAGER, RADIATION THERAPY, IYE ELEKTA LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1