BEUDAMED
    FDA Adverse Event Summary report: N

    CLINAC 2100 C/D

    MDR report key: 2506183 · Received March 20, 2012

    Report

    Report Number
    2916710-2012-00014
    Date Received
    March 20, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 20, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K913119
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN INVESTIGATION WAS CONDUCTED BY ANALYSIS OF THE INFORMATION OBTAINED FROM THE SITE BY THE LOCAL VARIAN FIELD SERVICE ENGINEER. THIS EVENT IS CONSIDERED TO BE USER ERROR BY THE SITE THERAPIST. NO MALFUNCTION OF THE VARIAN CLINAC OCCURRED. VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE, AS THIS SITUATION, SHOULD IT RECUR, COULD POTENTIALLY RESULT IN SERIOUS INJURY. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PT WAS BEING TREATED ON THE CLINAC 2100 CD AND THE THERAPIST WAS ROTATING THE GANTRY REMOTELY FROM OUTSIDE OF THE TREATMENT ROOM WHEN THE PT WAS STRUCK IN THE ABDOMEN BY THE GANTRY. THE THERAPIST WAS USING THE MANUAL SELECTION FROM THE DEDICATED KEYBOARD. WHEN THE THERAPIST REALIZED THAT THE PT WAS STRUCK, THE THERAPIST ENTERED THE TREATMENT ROOM, CHECKED ON THE PT, AND VERBALLY CONFIRMED THAT THE PT WAS NOT INJURED. THE REMAINING TREATMENT FIELDS WERE DELIVERED AND THE SESSION WAS COMPLETED. THE PT WAS LATER SEEN AT THE EMERGENCY ROOM AT ANOTHER HOSPITAL BUT DECLINED TO BE SEEN BY A PHYSICIAN. THE TREATING PHYSICIAN DID NOT FEEL THAT THE PT WAS SERIOUSLY INJURED AND THE CUSTOMER HAS DECLINED TO PROVIDE ANY FURTHER INFORMATION. NO REPORT OF SERIOUS INJURY HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC 2100 C/D ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H27

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR