BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINAC

    MDR report key: 2001785 · Received January 4, 2011

    Report

    Report Number
    2916710-2010-00150
    Event Type
    Other
    Date Received
    January 4, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K862645
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED INJURY IN THIS CASE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED A MDR IS APPROPRIATE AS THIS ISSUE IS AN APPARENT OCCURRENCE OF MISADMINISTRATION. ADD'L F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THERAPIST INADVERTENTLY RESUMED A PATIENT TREATMENT WITHOUT ENTERING THE PRIOR DELIVERED DOSE INTO THE APPROPRIATE IMPAC FIELD AND WITH GANTRY STILL A 0 DEG. IEC AND NO INTERLOCK ASSERTED BY TREATMENT PLAN SOFTWARE. THE THERAPIST NOTICED THE ERROR AFTER ONLY A FEW MU HAD BEEN DELIVERED AND TERMINATED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS 2100C/D

    Patients

    Seq Age Sex Outcome Treatment
    1