BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAINSCAN

    MDR report key: 851321 · Received May 11, 2007

    Report

    Report Number
    8043933-2007-00006
    Event Type
    Other
    Date Received
    May 11, 2007
    Date of Event
    April 10, 2007
    Report Date
    April 17, 2007
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOSE DATA IN QUESTION WAS IMPLEMENTED IN APRIL 2006 AND USED FOR TREATMENT OF 172 PATIENTS ACCORDING TO THE MEDICAL CENTER. PATIENT INJURY CAN NOT BE EXCLUDED AT THIS POINT OF TIME. THE FINAL CLINICAL EFFECT ON THE PATIENTS IS CURRENTLY UNDER INVESTIGATION BY THE HOSPITAL. SUMMARY OF EVALUATION: THE ADVERSE INCIDENT HAS BEEN RECOGNIZED / IDENTIFIED BY BRAINLAB AS "HUMAN ERROR".

    Description of Event or Problem · 1

    DURING AN INTERNAL REVIEW OF DOSE DATA ACROSS VARIOUS SITES, BRAINLAB DETECTED A DISCREPANCY IN THE DOSE DATA AT HOPITAL. VERIFICATION AND QUALITY ASSURANCE OF THE DOSE DATA IS THE RESPONSIBILITY OF THE DEVICE OWNER. NO MALFUNCTION OF THE DEVICE HAS BEEN EITHER REPORTED OR IDENTIFIED; PRELIMINARY INVESTIGATION BY BRAINLAB SHOWED THAT THE DEVICE IS WORKING AS INTENDED. THERE MAY HAVE BEEN INCORRECT DOSE MEASUREMENTS PERFORMED, IMPLEMENTED, AND USED AS DOES DATA FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAINSCAN RADIOTHERAPY TREATMENT PLANNING SYSTEM MUJ BRAINLAB AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other