BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1081742 · Received July 25, 2008

    Report

    Report Number
    8020711-2008-00004
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 2, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    KPQ
    PMA / PMN Number
    K033339
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL INFO INDICATES A POTENTIAL FOR INJURY. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE. ADD'L F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A FEW PTS HAVE BEEN MISTREATED, DUE TO A MALFUNCTION OF THE ACUITY WORKSTATION. THE PTS ARE PLANNED IN ECLIPSE AND PLANNING APPROVED. THIS PLAN IS OPEN ON THE ACUITY TO ACQUIRE IMAGES OF THE FIELDS (FIELDS WITH MLC). THE SYS DID NOT ALLOW SAVING OF THE IMAGE BECAUSE THE PLAN IS IN "PLANNING APPROVED" (NORMALLY, YOU ARE ALLOWED TO ADD A SIMULATION IMAGE TO A PLANNED APPROVED PLAN). THE PHYSICIST UNAPPROVED THE PLAN, DELETED THE DOSE ICON AND SAVED THE IMAGE. UNFORTUNATELY, FOR AN UNK REASON, THE MLC SHAPE HAS BEEN CHANGED. THE PLAN WAS APPROVED AND TREATED WITH THIS WRONG MLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY SIMULATOR KPQ VARIAN MEDICAL SYSTEMS H77-SIM

    Patients

    Seq Age Sex Outcome Treatment
    1