BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTREAM DRX-EVOLUTION SYSTEM

    MDR report key: 18852528 · Received March 6, 2024

    Report

    Report Number
    1317307-2024-00002
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 16, 2024
    Report Date
    March 4, 2024
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    KPR
    UDI-DI
    60889971739193
    PMA / PMN Number
    K091889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 THE SYSTEM MIGHT APPLY THE PREVIOUS TECHNIQUES DATA TO THE CURRENT VIEW FOR USE, RESULTING IN A HIGHER EXPOSURE. CARESTREAM IS WORKING THROUGH PROVIDING A SOFTWARE SOLUTION. A WORK-AROUND HAS BEEN PROVIDED TO THE CUSTOMER UNTIL THE NEXT RELEASE OF SOFTWARE WHICH CONTAINS A SOLUTION TO ADDRESS THIS TYPE OF ISSUE. 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 TO ERR ON THE SIDE OF CAUTION. 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. 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 (B)(6) 2024, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-EVOLUTION SYSTEM THAT OCCURRED ON (B)(6) 2024. THE PROBLEM DESCRIPTION OUTLINES A RADIATION DOSE HIGHER THAN EXPECTED. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175435 CARESTREAM DRX-EVOLUTION SYSTEM CARESTREAM DRX-EVOLUTION SYSTEM KPR CARESTREAM HEALTH INC. 60889971739193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other