BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBEAM

    MDR report key: 3068309 · Received July 26, 2006

    Report

    Report Number
    9710332-2006-00004
    Event Type
    Injury
    Date Received
    July 26, 2006
    Date of Event
    June 28, 2006
    Report Date
    July 20, 2006
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH
    Product Code
    JAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL INTELLIGENCE COUCH TOP IS LIKE, E.G., SIEMENS, SINMED, AND Q-FIX, A SOLID CARBON FIBRE COUCH TOP WITHOUT A TENNIS RACKET AREA. (B)(4). ALL CARBON FIBER TABLETOPS RESULT IN AN INCREASE IN PT SKIN DOSE AND ALL ARE AWARE OF THE INCREASE IN DOSE. THIS DESIGN ENABLES A HIGHER STABILITY FOR THESE COUCH TOPS AND MINIMIZES ANY SAGGING OF THE PT, WHICH CAN OCCUR WITH TRADITIONAL TENNIS RACKET INSERTS OR FOIL AND A NOTABLY IMPROVEMENT IMAGING QUALITY, COMPARED TO TENNIS RACKET TYPES. OVER THE COMPLETE TREATMENT AREA, SOLID CARBON FIBER COUCH TOPS DO NOT HAVE A HIGHER DOSE ATTENUATION COMPARED TO TENNIS RACKET AREAS. AS A CONSEQUENCE OF HIGHER ATTENUATION CAUSED BY THE SOLID CARBON FIBRE COUCH TOPS, THERE IS A, IN COMPARISON, NOTABLY HIGHER SKIN DOSE. EVEN VERY THIN CARBON FIBER SOLID INSERTS, TO BE PLACED IN THE TENNIS RACKET AREA, HAVE AN NOTABLE EFFECT ON SKIN DOSE UP TO (B)(4) RELATIVE SURFACE DOSE. SAME CAN BE NOTED WITH SEVERAL STATE OF THE ART IMMOBILIZATION DEVICES. CORRESPONDING (B)(4) CALCULATIONS DEMONSTRATE THAT THIS EFFECT TO SKIN DOSE CAN BE DECISIVELY COMPENSATED ONLY BY TENNIS RACKETS. THEREFORE, ALL SOLID CARBON FIBRE COUCH TOPS CAN BE STATED TO SHOW SIMILAR EFFECTS. THE EFFECT HAS TO BE CONSIDERED FOR ADAPTION OF TREATMENT TECHNIQUES. SHOULD THE USER EMPLOY THE SAME TECHNIQUES, AS FOR A COUCH TOP WITH TENNIS RACKET, SKIN REACTIONS ARE MORE LIKELY TO OCCUR. OPPOSITE, COUCH TOPS WITH A TENNIS RACKET AREA HAVE MASSIVE FRAME STRUCTURES, WHICH HAVE TO BE CONSIDERED IN TREATMENT PLANNING AS WELL. THIS IMPOSES THAT COUCHTOPS MAY NOT BE TREATED "AS AIR".

    Description of Event or Problem · 1

    THE PT WAS IN PROSTATE TREATMENT AND WAS TREATED WITH A BRAINLAB NOVALIS SYSTEM DIRECTLY WITH SKIN ON THE COUCH TOP. THE KIND OF TREATMENT WAS CONFORMAL BEAM. DURING THE TREATMENT, THE COUCH TOP "CAUSED THAT THE PATIENT GOT AN INCORRECT DOSE TREATMENT AND HAS DRY DESQUAMATION". REGION OF TREATMENT: PROSTATE. APPLIED RADIATION ENERGY AND MODALITY OF 6 MV. SIX FIELD TECHNIQUE WAS USED AND FIELD SIZE WAS ROUGHLY 6 CM X 7 CM. DELIVERED DOSE PER FRACTION OF 2 GY AT 90%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBEAM JAI MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other