BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEFINIUM 8000 DIGITAL RADIOGRAPHIC IMAGING SYSTEM

    MDR report key: 8915659 · Received August 21, 2019

    Report

    Report Number
    2126677-2019-00010
    Event Type
    Death
    Date Received
    August 21, 2019
    Date of Event
    July 17, 2019
    Report Date
    September 30, 2019
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    K051967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION HAS BEEN COMPLETED AND THE CAUSE OF THE EVENT WAS DETERMINED TO BE USE ERROR. THE GE FIELD ENGINEER WENT TO THE SITE TO INVESTIGATE THE SYSTEM AND FOUND THE SYSTEM WAS OPERATING CORRECTLY AS ALL FUNCTIONAL TESTING PASSED AND NO SYSTEM MALFUNCTION WAS IDENTIFIED. IN ADDITION, AN INTERVIEW WAS CONDUCTED WITH THE USER WHO CLARIFIED THE PATIENT WAS LYING HORIZONTALLY ON THE GURNEY WITH THEIR BACK LEANING AGAINST THE WALL STAND BUCKY. THE USER THEN ATTEMPTED TO TAKE AN X-RAY IMAGE, BUT THE SYSTEM WOULD NOT PRODUCE AN EXPOSURE. THE USER THEN SELECTED THE AUTO-POSITION BUTTON TO HOME THE TUBE SUSPENSION. AS THE AUTO-POSITIONING MOVEMENT STARTED TO RAISE THE WALL STAND BUCKY AND TUBE SUSPENSION VERTICALLY, IT CREATED A GAP BETWEEN THE WALLSTAND BUCKY AND GURNEY, WHICH LED TO THE PATIENT FALLING. AT ANY POINT DURING AUTO-POSITION, THE OPERATOR CAN RELEASE THE BUTTON AND ALL AUTO-POSITION MOVEMENT WILL BE STOPPED. THE SYSTEMS OPERATOR MANUAL ALSO CONTAINS SEVERAL WARNINGS APPLICABLE TO THIS EVENT. FIRST, THERE IS A WARNING THAT STATES MAKE SURE YOUR PATIENT DOES NOT USE THE WALL STAND AS A SUPPORT. THIS MEANS THE OPERATOR OF THE DEVICE SHOULD ENSURE THE PATIENT IS NOT LEANING ON THE WALL STAND BUCKY DURING USE AS IT IS NOT CONSIDERED A LOAD BEARING DEVICE. THE SECOND WARNING STATES, THE AREA 180CM IN FRONT OF THE WALL STAND SHOULD BE KEPT CLEAR DURING AUTO-POSITIONING. DUE TO THE MOVEMENT OF THE TUBE ASSEMBLY AND WALL BUCKY DURING AUTO-POSITIONING, THE OPERATOR SHOULD ENSURE THERE IS NO PATIENT STANDING IN THE DIRECT AREA OF THE SYSTEMS MOVING PARTS. AS A CORRECTION, THESE WARNINGS WERE REVIEWED WITH THE CUSTOMER. NO FURTHER ACTIONS ARE NEEDED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE HAS INITIATED AN INVESTIGATION WHICH IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE USER AT (B)(6) UNIVERSITY CLINICAL HOSPITAL IN (B)(6) REPORTED THAT ON (B)(6) 2019 DURING IMAGING, A (B)(6)-YEAR-OLD PATIENT WAS LYING HORIZONTALLY ACROSS A HOSPITAL GURNEY FACING THE DEFINIUM 8000 WALL STAND BUCKY (RIGHT DECUBITUS POSITION WITH ANTERIOR FACING WALL STAND BUCKY). THE CUSTOMER REPORTED THE PATIENT WAS LEANING AGAINST THE WALL STAND BUCKY AND SIMULTANEOUSLY, THE BUCKY ANGULATED APPROXIMATELY TWO TO THREE DEGREES WHICH ALLEGEDLY SCARED THE PATIENT. THE PATIENT FELL TO THE FLOOR, HITTING HER HEAD AND BACK AND WAS LATER DIAGNOSED WITH A SUBDURAL EFFUSION. THE PATIENT DECEASED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710282 DEFINIUM 8000 DIGITAL RADIOGRAPHIC IMAGING SYSTEM SYSTEM, X-RAY, STATIONARY KPR GE MEDICAL SYSTEMS, LLC 2374870

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death