BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINAC

    MDR report key: 1541485 · Received November 17, 2009

    Report

    Report Number
    2916710-2009-00061
    Event Type
    Injury
    Date Received
    November 17, 2009
    Date of Event
    October 12, 2009
    Report Date
    October 13, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K904364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN INTERVIEWED THE VARIAN SERVICE ENGINEER WHO SUBMITTED THE REPORT, PLUS ONE DEPARTMENT STAFF AT THE MEDICAL CENTER AND THE RISK MANAGEMENT MANAGER FOR THE FACILITY, AND RECEIVED CONFIRMATION THAT AN INCORRECT PATIENT HAD BEEN TREATED FOR ONE FRACTION. STAFF WERE NOT WILLING TO RELEASE INFORMATION ON THE BODY SITE THAT HAD BEEN TREATED, OR ANY FURTHER DETAILS. THE HOSPITAL DOES HAVE PHOTO ID CAPABILITY AS PART OF THEIR RECORD AND VERIFY SYSTEM, BUT APPARENTLY HAVE BEEN MAKING LESS THAN 100% USE OF THAT FUNCTIONALITY. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    A VARIAN SERVICE REP RECEIVED A REPORT FROM HIS WIFE (A NURSE AT THE HOSPITAL) THAT A WRONG PATIENT WAS TRANSPORTED WHERE THE PATIENT RECEIVED A THERAPEUTIC DOSE OF RADIATION IN THE CLINIC, ON ONE OF THE VARIAN'S TREATMENT DEVICES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other