BEUDAMED
    FDA Adverse Event Other Summary report: N

    IBEAM

    MDR report key: 2218750 · Received August 5, 2011

    Report

    Report Number
    9710332-2011-00001
    Event Type
    Other
    Date Received
    August 5, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 4, 2011
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH
    Product Code
    IXQ
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED IN COMBINATION WITH A VARIAN LINEAR ACCELERATOR AND A PHILIPS ADAC PINNACLE PLANNING SOFTWARE. IT APPEARS THAT DURING PLANING THE BUILD-UP EFFECT OF A SOLID MATERIAL, I.E. CARBON FIBRE BOARD WAS NOT CONSIDERED. THE BUILD-UP EFFECT IS EXTENSIVELY DESCRIBED IN THE INSTRUCTION FOR USE (IFU) TOGETHER WITH A DIRECTION TO CONSIDER SKIN-EFFECTS DURING PLANNING OF THE TREATMENT. THE ADAC PINNACLE SEEMS TO NOT AUTOMATICALLY ADJUST BUILD-UP EFFECTS AND THE USER ERROR COULD NOT BE CORRECTED.

    Description of Event or Problem · 1

    THERE HAS BEEN AT LEAST FOUR OCCASIONS WHERE A PT HAS BEEN BURNED DURING TREATMENTS. THIS IS HAPPENING WHEN THEY ARE COMPLETING A "PA" AND "AP" TREATMENT WHEN THE GANTRY IS FIXED AND APPLYING A DOSE. AS A RESULT OF THIS CONDITION THE PT(S) HAD TO BE TREATED FOR BURNS BY THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBEAM PATIENT POSITIONING SYSTEM IXQ MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization