BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1632468 · Received March 3, 2010

    Report

    Report Number
    8020711-2009-00010
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    December 5, 2009
    Report Date
    December 9, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    KPQ
    PMA / PMN Number
    K033339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN A DIGITAL SHAPE PROJECTOR (DSP) /FIELD APERTURE SHAPE IS CREATED, THE POSITION OF THE SHAPE DISPLAYED ON THE VISION MONITOR (CONTROL CONSOLE AREA), IS DIFFERENT FROM THE ACTUAL DSP SHAPE POSITION DISPLAYED ON THE COUCH/PT. THIS SHAPE POSITION ERROR OCCURS ONLY WHEN THE COLLIMATOR ANGLE IS AT A VALUE OTHER THAN 0 DEGREES. THE ERROR IS A ROTATIONAL SHIFT OF 90 DEGREES BETWEEN THE ACTUAL SHAPE ON THE COUCH AND THAT DISPLAYED ON THE VISION MONITOR. WHEN THE COLLIMATOR IS ROTATED BACK TO ZERO DEGREES, THE DISCREPANCY DISAPPEARS. NO SERIOUS INJURY TO THE PT WAS REPORTED.

    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