BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLINAC

    MDR report key: 776455 · Received August 9, 2006

    Report

    Report Number
    2916710-2006-00035
    Event Type
    Death
    Date Received
    August 9, 2006
    Report Date
    August 9, 2006
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    k904364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NP
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS INSUFFICIENT INFO AVAILABLE TO DETERMINE THE EXACT CAUSE OF THE INCIDENT. HOWEVER, THE CUSTOMER STATED IN SUBSEQUENT E-MAIL MESSAGES AND PHONE CONVERSATIONS WITH VARIAN PERSONNEL THAT "THE INCIDENT DIDN'T OCCUR DUE TO ANY MALFUNCTION OF THE EQUIPMENT INVOLVED IN THE TREATMENT SO WE DID NOT FEEL NECESSARY TO FILL THE INCIDENCE FORM." THERE ARE NO OTHER REPORTS ON RECORD OF SUCH AN EVENT OCCURRING ON A VARIAN TREATMENT COUCH. THE CUSTOMER IS UNWILLING TO DISCLOSE FURTHER DETAILS REGARDING THE INCIDENT AND HAS CONSIDERED THE CASE CLOSED. VARIAN SERVICE PERSONNEL OFFERED TO VISIT THE FACILITY TO INSPECT THE COUCH, BUT THE CUSTOMER AGAIN REITERATED THAT THERE WAS NO MALFUNCTION OF ANY VARIAN DEVICE. THERE ARE NO FIELD SERVICE REPORTS INDICATING ANY PROBLEMS OR REPAIRS ON THE CUSTOMER'S TREATMENT COUCH. NO ADD'L SUPPLEMENTS TO THIS MDR ARE EXPECTED, UNLESS NEW INFO INDICATES IT IS NECESSARY.

    Description of Event or Problem · 1

    IN 2006, VARIAN MEDICAL SYSTEMS RECEIVED AN E-MAIL FROM A PHYSICIAN AT CANCER CENTER INVOLVING A PT DEATH. THE CUSTOMER WROTE, "A PT WITH THE CASE OF MALIGNANT PERIPHERAL NERVE SHEATH TUMOR IN HIP WAS TREATED ON 20 MV PHOTON BEAM. DURING HIS 20TH FRACTION OF TREATMENT, THE PT FELL DOWN ALL OF A SUDDEN FROM THE TREATMENT COUCH AND EXPIRED ON SPOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS 27 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death