BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON BOARD IMAGING - OBI

    MDR report key: 2266047 · Received September 7, 2011

    Report

    Report Number
    2916710-2011-00122
    Event Type
    Malfunction
    Date Received
    September 7, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 11, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K040192
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN E-MAIL FROM COMPLAINT SUBMITTER WAS RECEIVED (B)(4) 2011 AND INDICATED: "AT THE 3RD BEAM, THE OPERATOR SAW ON THE VIDEO CAMERA THAT THE LEASERS DIDN'T MATCH THE SKIN MARKS, BUT HE DOESN'T KNOW AT WHICH EXACT MOMENT THE COUCH HAS MOVED. SO HE HAD TO PRESS THE "MOTION ENABLE BAR." THIS E-MAIL COMMUNICATION SUGGESTS THAT THE USER HAD TO PRESS THE MOTION UNABLE BAR FOR COUCH TO MOVE AND THE COUCH DID NOT MOVE ON ITS OWN; THIS INDICATES THAT THE USER LIKELY COMMITTED AN ACTION TO MOVE THE COUCH IN ERROR. THE VARIAN INVESTIGATION IS STILL DETERMINING THE DETAILS OF THIS COMPLAINT, AS THE PHYSICIST IN CHARGE OF THIS PROBLEM HAS BEEN ON VACATION. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. AS PART OF THIS INVESTIGATION, VARIAN HAS REQUESTED A MEDICAL ADVISER TO REVIEW THE REPORTED MISTREATMENT FOR POTENTIAL RISK OF SERIOUS INJURY. ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE LAST TREATMENT SESSION OF THE PELVIC AREA A PT, AN AUTOMATIC (UNEXPECTED) MOVEMENT OF THE TABLE OCCURRED AFTER THE PT WAS SETUP ON THE TABLE AND THE THERAPISTS WERE OUTSIDE THE TREATMENT ROOM. A MISTREATMENT/UNINTENDED DOSE TO THE SMALL INTESTINE AND FEMORAL HEAD OF 100 CGY WAS REPORTED AS A RESULT OF THIS REPORTED ISSUE; NO ADD'L PT STATUS HAS BEEN PROVIDED TO VARIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON BOARD IMAGING - OBI ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H08

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR