BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CR-35X SYSTEM WITH NX WORKSTATION

    MDR report key: 2040377 · Received February 15, 2011

    Report

    Report Number
    9613152-2011-00002
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    AGFA HEALTHCARE GMBH
    Product Code
    MQB
    PMA / PMN Number
    K041701
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: SINCE THE PROBLEM DID NOT OCCUR IN THE FIELD, SCENARIOS WERE CREATED TO TEST THE HYPOTHESIS BEHIND THE PROBLEM. SCENARIO: 2 FLFS EXAMS ACTIVE (PT A AND B). IDENTIFICATION OF THE FLFS THUMBNAILS OF PT A AND PT B. SEND FLFS IMAGES OF PT A, WAIT FOR AUTO-STITCH OF PT A. NAVIGATE TO VEE AND SELECT THE STITCH IMAGE OF PT A. NOW SEND THE FLFS IMAGES OF PT B. WHILE PERFORMING MEASUREMENTS (IN VIEWING AND EDITING) ON THE STITCHED IMAGE OF PT A, THE AUTO STITCHED IMAGE OF PT B ARRIVES IN THE NX VIEWER AND REPLACES THE FULL EDIT VIEW OF PT A. SIMULATION: CAN BE SIMULATED WITH MOCK-UPS. DISABLE AUTO SEND IN DIGITISER MOCK-UP. EXPECTED RESULT: THE STITCHED IMAGE OF PT A REMAINS VISIBLE. ACTUAL RESULT: THE STITCHED IMAGE OF PT B REPLACES THE IMAGE OF PT A. NOTES: THE ANNOTATION MADE PRIOR TO THE ARRIVAL OF STITCHED IMAGE B ARE KEPT IN IMAGE A. MEASUREMENTS/ANNOTATIONS PERFORMED ON STITCHED IMAGE B ARE CORRECTLY BOUND TO PT B. PROBLEM CAN OCCUR ON NX 8100/8200/8300 AND 8400.

    Description of Event or Problem · 1

    WHEN A RADIOGRAPHER IS WORKING ON TWO OPEN STUDIES ON A NX WORKSTATION, IN SPECIFIC SITUATIONS A PROBLEM OF IMAGE/ANNOTATION MIX-UP CAN OCCUR ON THE NX SYS. THIS ISSUE WAS FOUND INTERNALLY (NOT BY A CUSTOMER). WE ARE REPORTING IT HERE BECAUSE WE BELIEVE THAT POTENTIALLY SERIOUS INJURY COULD RESULT IF THE PROBLEM WERE TO RECUR IN THE FIELD. ALTHOUGH SEVERAL PRECONDITIONS MUST BE MET BEFORE THE PROBLEM CAN OCCUR THE RISK IS NOT ENTIRELY ELIMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CR-35X SYSTEM WITH NX WORKSTATION COMPUTED RADIOGRAPHY SYSTEM MQB AGFA HEALTHCARE GMBH NX 82/83/84/8500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other