BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTRAC

    MDR report key: 1686131 · Received May 11, 2010

    Report

    Report Number
    8043933-2010-00008
    Event Type
    Other
    Date Received
    May 11, 2010
    Date of Event
    April 13, 2010
    Report Date
    April 15, 2010
    Manufacturer
    BRAINLAB AG
    Product Code
    IYE
    PMA / PMN Number
    K040585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSP, NO ADVERSE CLINICAL EFFECT IS EXPECTED FOR THE 4 PTS IN QUESTION. THE HOSP STATES TO HAVE REPORTED THE SLIGHTLY EXCEEDED PLANNED TREATMENT MARGINS FOR ONE PT TO THE (B)(6). INCORRECT CALIBRATION BY THE USER RESULTED IN A DEVIATION OF THE INTENDED PT POSITION AT THE LINEAR ACCELERATOR. ACCORDING TO BRAINLAB MEASURES ARE IN PLACE FOR THE DEVICE IN QUESTION IN ORDER TO MINIMIZE THE RISK AS FAR AS REASONABLY POSSIBLE. THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF BRAINLAB EQUIPMENT. CORRECTIVE AND PREVENTIVE ACTIONS: SINCE THERE WAS NO QUALITY OR PERFORMANCE ISSUE OR MALFUNCTION OF BRAINLAB EQUIPMENT. ACCORDING BRAINLAB MEASURES ARE IN PLACE FOR THE DEVICE IN QUESTION IN ORDER TO MINIMIZE THE RISK AS FAR AS REASONABLY POSSIBLE. THERE ARE NO CORRECTIVE AND PREVENTIVE ACTIONS INTENDED BY BRAINLAB AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE BRAINLAB PT POSITIONING DEVICE EXACTRAC WAS INCORRECTLY CALIBRATED BY THE USER. AS A RESULT, THE RADIATION DOSE DELIVERED FROM THE LINEAR ACCELERATOR DEVIATED FROM THE INTENDED TARGET REGION FOR 4 PTS FOR ONE RADIATION FRACTION EACH IN BETWEEN (B)(6) 2010. NO FAILURE OF THE BRAINLAB DEVICE WAS STATED BY THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTRAC PATIENT POSITIONING SYSTEM IYE BRAINLAB AG EXACTRAC V. 5.0.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other