BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3720556 · Received March 19, 2014

    Report

    Report Number
    8020711-2014-00002
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 25, 2014
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    KPQ
    PMA / PMN Number
    K033339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN IS FILING THIS MDR BASED ON POTENTIAL INJURIES POTENTIALLY INVOLVING MULTIPLE PATIENTS. ADDITIONAL FOLLOW UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    VARIAN WAS ADVISED OF POTENTIAL MIS-ADMINISTRATIONS AT (B)(6). BASED ON REPORTED INFORMATION, THE SITE USES THE ACUITY SIMULATOR WITH FAD 80 MODE. THE REPORTS INDICATE THE PHYSICISTS DID NOT USE THE FIELD SIZE VALUES DISPLAYED ON THE ACUITY SIMULATOR. INSTEAD, THEY INCREASED THE TARGET AREAS ON THE LINEAR ACCELERATOR BY 20%, BELIEVING THEY WERE ADJUSTING FOR DIVERGENCE. THIS WAS UNNECESSARY AS THE ACUITY AUTOMATICALLY SIMULATES THE FAD 80 TECHNIQUE OF THE VARIAN LINEAR ACCELERATOR. AS A RESULT, MIS-ADMINISTRATION MAY HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162612 ACUITY SIMULATOR KPQ VARIAN MEDICAL SYSTEMS H770498-SIM

    Patients

    Seq Age Sex Outcome Treatment
    1