BEUDAMED
    FDA Adverse Event Other Summary report: N

    XIMATRON

    MDR report key: 1662416 · Received April 13, 2010

    Report

    Report Number
    8020711-2010-00004
    Event Type
    Other
    Date Received
    April 13, 2010
    Report Date
    March 18, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    KPQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL REPRESENTATIVE WOULD NOT PROVIDE ANY ADD'L DETAILS REGARDING THE INCIDENT OR PT INFO. HOWEVER, THE MACHINE HAS BEEN REMOVED AND IS NO LONGER AT THE FACILITY. VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, DUE TO THE INDICATION OF INJURY. NO ADD'L F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    VARIAN RECEIVED A CALL FROM AN ATTORNEY CALLING ON BEHALF OF (B)(6). IT WAS REPORTED THAT IN (B)(6) 2008, THE HOSPITAL HAD A PT THAT "ROLLED HERSELF OFF" THE TABLE DURING TREATMENT - ON A VARIAN XIM. THE ATTORNEY DID NOT PROVIDE ANY OTHER PT INFO. THE DEVICE MODEL AND SERIAL NUMBER WAS NOT PROVIDED AND THERE WAS NO ALLEGATION THAT THE INCIDENT WAS THE FAULT OF VARIAN OR RELATED TO ANY DEVICE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIMATRON SYSTEM, SIMULATION, RADIATION THERAPY KPQ VARIAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other