BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX-EVOLUTION PLUS AUTOMATIC - DUAL BUCK

    MDR report key: 13467817 · Received February 6, 2022

    Report

    Report Number
    1317307-2022-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2022
    Date of Event
    December 21, 2021
    Report Date
    February 4, 2022
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    KPR
    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

    ON (B)(6) 2022, CARESTREAM HEALTH INC RECEIVED A USER FACILITY REPORT, REFERENCE NUMBER (B)(4) VIA EMAIL FROM HEALTH PRODUCTS REGULATORY AUTHORITY (HPRA) IN IRELAND REGARDING A DRX-EVOLUTION SYSTEM WITH DIRECTVIEW SOFTWARE V 5.7: INCORRECT EXPOSURE FACTORS SELECTED USING AUTO. THE HPRA REQUIRED A MANUFACTURER'S INCIDENT REPORT, AS A RESULT, AN FDA REPORT WILL BE COMPLETED. PER THE INVESTIGATION AND LOGS REVIEW: ON (B)(6) 2021 AT 15:49, A COMMUNICATION FAILURE BETWEEN TWO DIRECTVIEW PROCESSES OCCURRED. EVIDENCE SHOWS THAT THE FAILURE HAPPENED IN A MICROSOFT SOFTWARE LAYER THAT THE DIRECTVIEW APPLICATION DEPENDS ON FOR THE COMMUNICATIONS. THE EXACT CAUSE OF THE MICROSOFT SOFTWARE LAYER FAILURE CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE DIM (DR INTERFACE MANAGER) PROCESS IS THE CSH SOFTWARE LAYER AT WHICH HARDWARE COMMUNICATIONS ARE MANAGED. THE GUI (GRAPHICAL USER INTERFACE) LAYER IS THE CSH SOFTWARE LAYER AT WHICH TECHNIQUES ARE MANAGED AND DISPLAYED TO THE USER. WHEN THE COMMUNICATION FAILURE HAPPENED, THE GUI STOPPED RECEIVING UPDATES FROM THE DIM ABOUT WHICH HARDWARE DEVICE WAS PARTICIPATING IN EXPOSURE SEQUENCES. THE GUI'S VIEW WAS THAT A CR CASSETTE WAS STILL BEING USED. THE DIM RECEIVED SUBSEQUENT UPDATES INFORMING IT THAT A DR DETECTOR WAS BEING USED. FOLLOWING THE COMMUNICATION FAILURE, THE SYSTEM CONTINUED TO SET CR TECHNIQUES. THE SITE CONTINUED TO MAKE EXPOSURES BETWEEN (B)(6) WITHOUT MANUALLY ADJUSTING ANY TECHNIQUES OR REJECTING FOR EXPOSURE ISSUES. PER CSH SAFETY AND REGULATORY GUIDE, AF4684, PAGE 1-3 USABILITY, TRAINING: "THIS EQUIPMENT IS INTENDED FOR USE BY APPROPRIATELY EDUCATED AND SKILLED RADIOLOGICAL HEALTH CARE PROFESSIONALS WHO HAVE RECEIVED SPECIFIC TRAINING ON THE OPERATION AND USE OF THIS EQUIPMENT." IT IS EXPECTED A SKILLED AND TRAINED RADIOLOGICAL HEALTH CARE PROFESSIONAL IS VERIFYING TECHNIQUES TO BE USED PRIOR TO EVERY EXPOSURE. ON (B)(6) 2021, THE USER REBOOTED THE SYSTEM. AT THIS TIME, THE GUI RESUMED RECEIVING UPDATES FROM THE DIM. THIS ALLOWED THE SYSTEM TO AGAIN USE THE CORRECT TECHNIQUES. THIS WAS A 1X OCCURRENCE AND ROOT CAUSE CANNOT BE DETERMINED. TO DATE CSH HAS NOT BEEN INFORMED OF ANY OTHER OCCURRENCE OF THIS FAILURE MODE ON ANY OTHER CUSTOMER MACHINES. HOWEVER, CSH HAS PROVIDED RECOMMENDATIONS AS FOLLOWS TO MITIGATE EXPOSURE ISSUES: FOLLOW THE ESTABLISH PROTOCOLS FOR USE BY APPROPRIATELY EDUCATED AND SKILLED RADIOLOGICAL HEALTH CARE PROFESSIONALS FOR CONFIRMING TECHNIQUES PRIOR TO EACH EXPOSURE AND REVIEWING EXPOSURE LEVELS AFTER EACH EXAM. CONSIDER CONFIGURING CR TECHNIQUES TO MATCH DR CSI TECHNIQUES FOR EXAMS THAT ARE SHOT WITH DR DETECTORS (E.G., DR LLI EXAMS) TO MITIGATE THIS TYPE OF ISSUE, IT IS RECOMMENDED TO PERFORM A FULL POWER CYCLE OF THE EQUIPMENT AT LEAST ONCE PER WEEK. CSH HAS CONCLUDED THIS INVESTIGATION. NOTE: THERE IS NO UDI NUMBER AVAILABLE IN THIS FORM AS THIS SYSTEM WAS MANUFACTURED ON NOVEMBER 2015, PRIOR TO UDI IMPLEMENTATION.

    Description of Event or Problem · 0

    ON (B)(6) 2021, CARESTREAM HEALTH RECEIVED A NOTIFICATION FROM THE HPRA REGARDING A USER FACILITY REPORT (B)(4), AS FOLLOWS: THE REPORT OUTLINES: INCORRECT EXPOSURE FACTORS SELECTED USING AUTO. THE PC WAS REPLACED TWICE IN (B)(6) 2021 TO RECTIFY THE ISSUES BUT THEY STILL OCCUR ALONG WITH OTHER NEW ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798386 DRX-EVOLUTION PLUS AUTOMATIC - DUAL BUCK DRX-EVOLUTION PLUS AUTOMATIC - DUAL BUCK KPR CARESTREAM HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other