BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 2845047 · Received November 9, 2012

    Report

    Report Number
    1317307-2012-00010
    Event Type
    Other
    Date Received
    November 9, 2012
    Date of Event
    September 29, 2012
    Report Date
    November 9, 2012
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CARESTREAM REVIEWED ALL THE UNIT'S SOFTWARE LOGS. THE SOFTWARE LOGS SHOWED THAT THERE WAS A PT SELECTION MADE IN EACH CASE. IN NO CASE WAS THE CAUSE ASSOCIATED WITH THE DRX-REVOLUTION SOFTWARE MIS-ASSIGNING THE IMAGE (FOR EXAMPLE THROUGH ELECTRICAL INTERFERENCE OR OTHER CAUSE). THE IMAGES WENT TO THE LOCATION SELECTED FROM THE TOUCH SCREEN. ROOT CAUSE WAS DETERMINED TO BE INADVERTENT PT SELECTION BY THE OPERATOR OF THE MOBILE X-RAY UNIT. THE DRX-REVOLUTION MOBILE X-RAY SYSTEM HAS FAILURE MODES ASSOCIATED WITH INADVERTENT OPERATOR SELECTIONS ON IT'S TWO TOUCH SCREENS (MAIN SCREEN ON THE CART AND SUB-SCREEN ON THE TUBE HEAD). CARESTREAM HEALTH WILL UPDATE THE APPLICATIONS CONSULTANT TRAINING TO HAVE THEM REMIND THE USERS THAT THE TOUCH SCREEN RESPONDS TO ANY TOUCH WHETHER INTENDED OR NOT. ADD THE FOLLOWING STATEMENT TO THE USER GUIDE: NOTE: CARESTREAM PRODUCTS UTILIZE TOUCH SCREEN CAPABLE MONITORS AND AS SUCH, ANY INTERACTION WITH THE MONITORS, INTENTIONAL OR UNINTENTIONAL, WILL INDUCE AN ACTION ON THE SCREEN. ISSUE A SOFTWARE UPDATE, WHICH WILL ELIMINATE THE KNOWN FACTORS CAUSING THE CONSOLE AND TUBE HEAD SCREENS TO BE OUT OF SYNCH. ALSO, IF THE SCREENS ARE OUT OF SYNCH, THE UNIT WILL NOT ACCEPT AN INPUT FROM THE TUBE HEAD SCREEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT IS ASSIGNING IMAGES TO THE WRONG PT'S INFO. THEY WERE ABLE TO EVENTUALLY GET THE IMAGES ASSIGNED TO THE CORRECT PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRX-REVOLUTION MOBILE X-RAY SYSTEM MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH, INC. DRXR-1

    Patients

    Seq Age Sex Outcome Treatment
    1