BEUDAMED
    FDA Adverse Event Other Summary report: N

    COUCHMOUNT VARIAN EXACT

    MDR report key: 1235673 · Received November 12, 2008

    Report

    Report Number
    8043933-2008-00006
    Event Type
    Other
    Date Received
    November 12, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 11, 2008
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN NO PT INJURY; HOWEVER, A RISK TO PT HEALTH COULD NOT BE EXCLUDED. SUMMARY OF EVAL: THE BRAINLAB DEVICE (INCLUDING THE LOCKING MECHANISM) WORKS AS INTENDED. THERE IS NO UNANTICIPATED RISK WITH THE BRAINLAB DEVICE DESIGN RELATED TO THIS OCCURRENCE. THE SITUATION OCCURRED DUE TO AN ERROR OF USE SINCE ACCORDING USER INSTRUCTION AS CONTAINED IN THE USER MANUAL HAVE NOT BEEN FULLY APPLIED IN THIS CASE (VERIFY THAT THE COUCHMOUNT IS SECURELY LOCKED EVERY TIME THE COUCHMOUNT IS ATTACHED). CORRECTIVE AND PREVENTIVE ACTION: THE USER HAS BEEN REMINDED ABOUT THE ACCORDING INSTRUCTIONS AND WARNINGS IN THE USER MANUAL REGARDING THE USE OF THE COUCHMOUNT.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT THE BRAINLAB COUCHMOUNT WAS DISPLACED FROM ITS POSITION, DUE TO A COLLISION WITH THE LINEAR ACCELERATOR. NO PT INJURY OCCURRED ACCORDING TO THE HOSP, HOWEVER, A RISK TO A PT HEALTH COULD NOT BE EXCLUDED, SINCE THE COUCHMOUNT IS USED TO FIXATE THE PT'S HEAD TO THE TREATMENT COUCH OF THE LINEAR ACCELERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUCHMOUNT VARIAN EXACT COUCHMOUNT VARIAN EXACT MUJ BRAINLAB AG 40100-0B NA

    Patients

    Seq Age Sex Outcome Treatment
    1