BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINAC 2100 C

    MDR report key: 583107 · Received March 17, 2005

    Report

    Report Number
    2914292-2005-00002
    Event Type
    Injury
    Date Received
    March 17, 2005
    Report Date
    March 15, 2005
    Manufacturer
    VARIAN ONCOLOGY SYSTEMS
    Product Code
    IYE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IN FEBRUARY 2005, VARIAN MEDICAL SYSTEMS WAS SERVED WITH A LAWSUIT. THE SUIT CLAIMS THAT THE PLAINTIFF SUFFERED SERIOUS AND PERMANENT INJURIES. HOWEVER, THERE IS NO SPECIFIC INFORMATION RELATIVE TO THE NATURE AND SEVERITY OF THE INJURIES. THE SUIT CLAIMS THE PLAINTIFF WAS MISTREADED FOR 2 MONTHS IN 2003 AS A RESULT OF DEFECTIVE RADIATION EQUIPMENT AND COMBINED NEGLIGENCE ON THE PART OF THE HOSPITAL CORPORATION, THE SPECIFIC HOSPTIAL, THE TREATING PHYSICIAN, AND HOSPITAL STAFF. VARIAN HAS NO RECORD OF BEING CONTACTED BY THE HOSPITAL REGARDING THIS INCIDENT. THERE IS NOT SUFFICIENT INFORMATION AVAILABLE AT THIS TIME TO CONCLUDE WHETHER THE EQUIPMENT MALFUNCTIONED, AND IF SO WHETHER THAT MALFUNCTION WOULD LEAD TO SERIOUS INJURY. HOWEVER, SINCE THERE IS AN ALLEGATION OF SERIOUS AND PERMANENT INJURIES, THIS MDR IS BEING FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC 2100 C LINEAR ACCELERATOR IYE VARIAN ONCOLOGY SYSTEMS 2100 C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other