BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTRAC INFRARED TRACKING PLATFORM 5.0, 5.5

    MDR report key: 1084549 · Received July 30, 2008

    Report

    Report Number
    8043933-2008-00004
    Event Type
    Other
    Date Received
    July 30, 2008
    Date of Event
    May 5, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BRAINLAB AG
    Product Code
    IXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN NO PATIENT OR USER INJURY REPORTED BY THIS OR ANY OTHER HOSPITAL HOWEVER A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED. SUMMARY OF EVALUATION: THIS POTENTIAL PROBLEM COULD BE REPRODUCED AT BRAINLAB USING THE SAME SW VERSIONS OF EXACTRAC AS THE INITIAL REPORTER. CORRECTIVE AND PREVENTIVE ACTION. - PRODUCT NOTIFICATION- EXISTING EXACTRAC CUSTOMERS WILL RECEIVE A PRODUCT NOTIFICATION INFORMATION. - BRAINLAB WILL PROVIDE A SOFTWARE UPDATE FOR THE AFFECTED EXACTRAC 5.0.2 AND 5.5.1 CUSTOMER.

    Description of Event or Problem · 1

    DURING SET-UP OF THE PATIENT WITH THE EXACTRAC AUTO-POSITIONING PROCESS, THE USER RECOGNIZED WHILE VISUALLY MONITORING THE PATIENT THAT THE COUCH CONTINUED DRIVING BEYOND THE PLANNED TREATMENT POSITION. THE OPERATOR RELEASED THE MOTION ENABLE KEYS TO STOP THE COUCH MOVEMENT. THERE HAS BEEN NO PATIENT OR USER INJURY REPORTED BY ANY HOSPITAL HOWEVER UNDER THE OBSERVED RARE CIRCUMSTANCES A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED. THE ROOT CAUSE AND THE ACCORDING CORRECTIVE ACTION DECISION FROM BRAINLAB'S INVESTIGATION WAS CONCLUDED ON JULY 17,2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTRAC INFRARED TRACKING PLATFORM 5.0, 5.5 EXACTRAC IXG BRAINLAB AG 5.0,5.5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1