BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTRAC X-RAY 6D FOR PLATFORM 5.5

    MDR report key: 1286777 · Received January 12, 2009

    Report

    Report Number
    8043933-2009-00001
    Event Type
    Other
    Date Received
    January 12, 2009
    Date of Event
    November 28, 2008
    Report Date
    January 12, 2009
    Manufacturer
    BRAINLAB AG
    Product Code
    IYE
    PMA / PMN Number
    K072506
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSP STATES TO HAVE SENT A REPORT TO (B)(6). ACCORDING TO THE HOSP: THE PT AND THE REFERRING PHYSICIAN WERE NOTIFIED. THE LIST OF POTENTIAL EFFECTS INCLUDE: BLINDNESS AND PANHYPOPITUITARISM. THE LIST OF POTENTIAL, BUT LESS LIKELY, EFFECTS INCLUDES PARALYSIS AND DEATH. BASELINE EXAMINATIONS OF THE PT BY SUBSPECIALISTS IN THESE AREAS AT THE INSTITUTION HAVE ALREADY BEGUN. USER DID NOT REPORT ANY MALFUNCTION OF THE BRAINLAB DEVICE.

    Description of Event or Problem · 1

    ON DEC 16, 2008, BRAINLAB WAS MADE AWARE BY THE CUSTOMER OF THE FOLLOWING OCCURENCE: THE PT WAS POSITIONED AT THE LINEAR ACCELERATOR USING THE ROOM LASERS. THE USER WANTED TO ADDITIONALLY VERIFY THE POSITION OF THE PT AT THE LINEAR ACCELERATOR BY USING THE BRAINLAB EXACTRAC DEVICE. A DECISION WAS MADE TO NOT CONTINUE TO USE EXACTRAC, AND THUS THE PT POSITIONING WORKFLOW WAS NOT COMPLETED. THE USER DID NOT RE-ADJUST THE PT BACK TO THE INITIAL, INTENDED TREATMENT POSITION BY MEANS OF THE ROOM LASERS BEFORE IRRADIATING THE PT IN THE INCORRECT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTRAC X-RAY 6D FOR PLATFORM 5.5 EXACTRAC IYE BRAINLAB AG SW VERSION 5.5.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other