BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAINLAB TARGET POSITIONER

    MDR report key: 834919 · Received March 30, 2007

    Report

    Report Number
    8043933-2007-00002
    Event Type
    Other
    Date Received
    March 30, 2007
    Report Date
    March 30, 2007
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS CURRENTLY NO INDICATION THAT THE MFR'S DEVICE MALFUNCTIONED; HOWEVER, USER ERROR CAN NOT BE EXCLUDED AT THIS POINT OF TIME. ANOTHER POTENTIAL ROOT CAUSE COULD BE INACCURATE IMPLEMENTATION OF MFR IN A THIRD PARTY TREATMENT PLANNING SOFTWARE. MFR WILL CONTINUE TO TRY TO WORK TOGETHER WITH THE THIRD PARTY MEDICAL DEVICE MANUFACTURERS AT THIS CUSTOMER SITE IN ANOTHER COUNTRY IN ORDER TO IDENTIFY THE ROOT CAUSE OF THE PROBLEM. AT THE PRESENT TIME, ALL REQUESTS FOR FURTHER INFO AT THIS CUSTOMER SITE HAVE NOT BEEN SUCCESSFUL.

    Description of Event or Problem · 1

    A THIRD PARTY MEDICAL DEVICE MANUFACTURER INFORMED MFR THAT MFR'S HARDWARE, USED IN COMBINATION WITH THE HARDWARE AND SOFTWARE OF OTHER MEDICAL DEVICE MANUFACTURERS, MAY HAVE BEEN INVOLVED IN A POSSIBLE INACCURATE RADIOTHERAPY/RADIOSURGERY TREATMENT OF MULTIPLE PT'S AT THE MEDICAL CENTER. THUS, FAR THE ACTUAL TREATMENT OUTCOMES HAVE NOT BEEN DIRECTLY COMMUNICATED OR VERIFIED TO BRAINLAB FROM THE MEDICAL CENTER, ANOTHER COUNTRY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAINLAB TARGET POSITIONER STEREOTACTIC RADIOTHERAPY ACCESSORY MUJ BRAINLAB AG * *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other