BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMR40 RETROFIT KIT

    MDR report key: 6926628 · Received October 7, 2017

    Report

    Report Number
    3004938766-2017-00010
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    September 21, 2017
    Report Date
    October 6, 2017
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    KPR
    UDI-DI
    10815411020298
    PMA / PMN Number
    K171085
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DESIGN MODIFICATION WILL BE IMPLEMENTED TO THE DETECTOR BIN. THIS SYSTEM HAS BEEN TAKEN OUT OF SERVICE UNTIL THIS MODIFICATION IS PUT IN PLACE. ADDITIONALLY, THE FOOT CRUSH LABEL WILL BE ADDED TO ALL SYSTEMS IN THE FIELD AND/OR IN INVENTORY. THE NOTED DESIGN MODIFICATION, WHICH WILL FOCUS ON RAISING THE GAP DISTANCE TO A MORE ACCEPTABLE LEVEL WHERE THIS INJURY WILL NOT RECUR OR OTHER LIKE SOLUTION. A CUSTOMER SERVICE BULLETIN WILL BE FORMALIZED TO DETAIL THIS SITUATION AND COMMUNICATE IT TO ALL APPLICATION AND SERVICE STAFF.

    Description of Event or Problem · 1

    THE X-RAY TECHNOLOGIST, WHILE TRANSPORTING PORTABLE MACHINE WITH THE RETROFIT EQUIPMENT IN A BACKWARDS MOTION CAUGHT HER LEFT FOOT FROM THE UNDERSIDE OF THE DETECTOR BIN OF THE RETROFIT UNIT WHERE IT SITS CLOSE TO THE FLOOR. THIS CAUSED AN INJURY TO HER FOOT (I.E. BRUISING AND INDUCED PAIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705971 GMR40 RETROFIT KIT DIGITAL RADIOGRAPHY GMR40 KPR NEUROLOGICA CORPORATION GMR40 10815411020298

    Patients

    Seq Age Sex Outcome Treatment
    1 Other