BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONBOARD IMAGER

    MDR report key: 3372894 · Received September 19, 2013

    Report

    Report Number
    2916710-2013-00019
    Event Type
    Injury
    Date Received
    September 19, 2013
    Date of Event
    August 5, 2013
    Report Date
    August 6, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K040192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DATA REVIEWED, THERE IS EVIDENCE THAT THE ISOCENTER OF THE TREATMENT FIELD AND THE ISOCENTER OF THE MATCH RESULTS ARE DIFFERENT AS THE COUCH DELTA FROM THE OBI MATCH RESULTS HAVE BEEN SAVED TO THE DATABASE BUT NOT APPLIED TO THE COUCH BY THE USER. THERE MADE THE CHOICE TO NOT APPLY THE SHIFTS THEY MANUALLY MADE WHEN REVIEWING THE IMAGE. THERE WAS NO INDICATION OF A TECHNICAL FAILURE WHEN OBSERVING THE OFFLINE REVIEW PROGRAM FUNCTIONALITY OR THE DATA SET IN THE ARIA DATABASE. THE SYSTEM WORKS AS SPECIFIED. THE FACILITY HAS REVIEWED THEIR PROCESS AND PLACED A NEW PROCESS IN EFFECT TO AVOID THIS FROM HAPPENING IN THE FUTURE. AS A RESULT OF THE ABOVE, VARIAN ATTRIBUTES THIS EVENT TO USE ERROR. THIS REPORT HAS BEEN SUBMITTED AS AN ADVERSE EVENT AS THE IMAGE AND COUCH VALUES DOCUMENTED RAISE THE POSSIBILITY THAT THE PT RECEIVED AT LEAST ONE FRACTION OF TREATMENT WITH THE COUCH IMPROPERLY POSITIONED. HOWEVER, VARIAN'S MEDICAL PROFESSIONAL CANNOT DETERMINE WHETHER SERIOUS INJURY OCCURRED IN THE ABSENCE OF REQUESTED PT INFO FROM THE SITE. VARIAN DOES NOT ANTICIPATE FURTHER F/U TO THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    THERAPIST SET UP THE PT IN THE ROOM. PT WAS IMAGED USING CBCT. AUTOMATCH OR MANUAL MATCH PERFORMED. SAVE MATCH WAS SELECTED AND THEN CANCEL. SHIFTS WERE NOT APPLIED TO THE PT. ACTUAL POSITION VALUES WERE ACQUIRED AT SOME POINT DURING THE PROCESS. THE MISMATCH WAS DISCOVERED BY A PHYSICIAN DURING OFFLINE REVIEW. THE CUSTOMER STATES THAT THERE IS AN ISSUE WITH THE ONLINE MATCH PROCESS AND DOCUMENTATION PROVIDED SUGGESTED THAT THERE MAY HAVE BEEN AN INJURY. HOWEVER, ACCORDING TO VARIAN'S MEDICAL REVIEW, BECAUSE THE SITE IS NOT WILLING TO PROVIDE ADD'L INFO NEEDED TO MAKE AN ASSESSMENT INCLUDING WHERE THE PT WAS TREATED, THE DIAGNOSIS, THE PLANNED WHERE THE PT WAS TREATED, THE DIAGNOSIS, THE PLANNED DOSE DELIVERED, THE ACTUAL DOSE DELIVERED AND ANY CORRECTIVE ACTIONS TAKEN, THERE IS INSUFFICIENT INFO UPON WHICH TO RENDER A MEDICAL PROFESSIONAL ASSESSMENT WHETHER THIS EVENT MAY HAVE CAUSED OR CONTRIBUTED TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472524 ONBOARD IMAGER ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H08

    Patients

    Seq Age Sex Outcome Treatment
    1 Other