BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 19655744 · Received July 2, 2024

    Report

    Report Number
    1317307-2024-00007
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    January 22, 2024
    Report Date
    July 1, 2024
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CARESTREAM HEALTH (CSH) HAS INVESTIGATED THIS ISSUE. THE INVESTIGATION DETERMINED THAT THERE WAS DIRT AROUND THE BEZEL OF THE TOUCHSCREEN WHICH CAUSED FALSE TOUCHES INCREASING THE MAS TECHNIQUES AND RESULTING IN A HIGHER EXPOSURE. THE FE CLEANED THE TOUCHSCREEN AND TESTED IT SUCCESSFULLY WITH NO RE-OCCURRENCES. THE FE ALSO REITERATED TO THE SITE THE IMPORTANCE TO FOLLOW THE BEST PRACTICES GUIDE PROVIDED BY CSH AND FOLLOW THE RECOMMENDATIONS TO PROPER CLEAN THE TOUCHSCREEN. USERS HAVE VISIBILITY TO TECHNIQUES ON THE USER INTERFACE; IT IS EXPECTED THAT A SKILLED AND TRAINED RADIOLOGICAL HEALTH CARE PROFESSIONAL VERIFIES ALL TECHNIQUES PRIOR TO EVERY EXPOSURE. PER RADIATION SAFETY, BASED ON THE TECHNIQUES USED, THE RISK TO THIS PATIENT FROM THESE IMAGES IS MINIMAL. THE ADDITIONAL RADIATION DOSE IS WELL BELOW THAT WHICH WOULD RESULT IN ANY PROMPT EFFECTS LIKE SKIN ERYTHEMA, AND THE ADDITIONAL RISK FROM STOCHASTIC EFFECTS IS NEGLIGIBLE; HOWEVER, CSH WILL REPORT THIS INCIDENT AS THE DOSE EXCEEDED 10X THE INTENDED DOSE STABLISHED BY UK REGULATIONS. IF THE ISSUE WERE TO RE-OCCUR, IT MAY REQUIRE A REPEAT IMAGE/RE-EXPOSURE. A RE-EXPOSURE WILL NOT LEAD TO A SERIOUS INJURY. IT WAS DETERMINED THAT THE 2 OTHER INCIDENTS REPORTED IN THIS SAME USER FACILITY REPORT HAD THE SAME ROOT CAUSE OF DIRTY TOUCHSCREENS WHICH RESULTED IN A CHANGE OF TECHNIQUES; HOWEVER, THEY DID NOT RESULT IN PATIENT OVEREXPOSURE, BOTH INCIDENTS OCCURRED DURING QUALITY TESTING AND; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. THERE ARE NO FURTHER ACTIONS TO BE TAKEN BY CARESTREAM HEALTH RELATED TO THIS ISSUE. CARESTREAM HAS COMPLETED THIS INVESTIGATION.

    Description of Event or Problem · 0

    ON 06-JUN-2024, CARESTREAM HEALTH INC. WAS INFORMED BY UK MHRA OF THREE INCIDENTS RELATED TO THE DRX-REVOLUTION SYSTEM VIA USER FACILITY REPORT. THE PROBLEM DESCRIPTION OUTLINES A RADIATION DOSE HIGHER THAN EXPECTED. NO INJURIES WERE REPORTED. NOTE: THERE IS NO UDI NUMBER AVAILABLE IN SECTION 2.1 OF THIS FORM AS THIS SYSTEM WAS MANUFACTURED ON NOVEMBER 2015, PRIOR TO UDI IMPLEMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507502 DRX REVOLUTION MOBILE X-RAY SYSTEM DRX REVOLUTION MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other