BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 4013941 · Received June 20, 2014

    Report

    Report Number
    2916710-2014-00005
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN IS FILING THIS MDR BASED ON A POTENTIAL PATIENT INJURY. ADDITIONAL FOLLOW UP TO THIS MDR IS EXPECTED UPON COMPLETION OF OUR INVESTIGATION. VARIAN REF. (B)(4).

    Description of Event or Problem · 1

    PATIENT RECEIVED INCORRECT DOSE OF MONITOR UNITS DURING RADIATION TREATMENT. PLANNED MONITOR UNITS: 15+15+31+34. ACTUAL MONITOR UNITS DELIVERED: 208+295+225+246. THE ATTENDING PHYSICIAN INTENDS TO MODIFY THE PATIENT'S TREATMENT PLAN OR THERAPY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363703 ARIA RADIATION ONCOLOGY ACCELERATOR, LINEAR MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. HIT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other