BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINAC

    MDR report key: 2948121 · Received November 26, 2007

    Report

    Report Number
    2914292-2007-00047
    Event Type
    Other
    Date Received
    November 26, 2007
    Date of Event
    September 1, 2004
    Report Date
    September 12, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS,
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORT OF THIS ALLEGED ADVERSE EVENT WAS RECEIVED BY VARIAN PRIOR TO THE LEGAL SUMMONS, ALTHOUGH THE EVENT WAS REPORTED TO OCCUR ON (B)(6) 2004. AN INITIAL REVIEW OF SERVICE REPORTS FOUND NO REPORTED MALFUNCTIONS OR ADVERSE EVENTS FROM THIS FACILITY FOR THE DATE REFERENCED BY THE SUMMONS. THIS REPORT OF AN ADVERSE EVENT IS UNDER INVESTIGATION. ((B)(4)).

    Description of Event or Problem · 1

    VARIAN MEDICAL SYSTEMS (VMS) RECEIVED A SUMMONS NOTIFYING VMS OF PRODUCT LIABILITY LITIGATION FOR PERSONAL INJURY, ON BEHALF OF A PT APPARENTLY TREATED WITH VMS RADIATION THERAPY DEVICES. THE SUMMONS CLAIMS THAT ON (B)(6) 2004, A LINEAR ACCELERATOR MALFUNCTIONED WHILE PT WAS RECEIVING RADIATION THERAPY AT MONTEFIORE MED CTR, RESULTING IN SERIOUS INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS, 21EX

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability