BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX-COMPASS SYSTEM

    MDR report key: 23866154 · Received December 22, 2025

    Report

    Report Number
    3004105475-2025-00005
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 22, 2025
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    KPR
    UDI-DI
    60889978624188
    PMA / PMN Number
    K201373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 THIS IS A HARDWARE ISSUE (DAP CABLE STABILITY ISSUE). THE LOGS INDICATED A LOOSE/UNSTABLE CONNECTION OF THE DAP UNIT. WHEN THIS OCCURS (DAP CABLE DISCONNECTED), IMAGEVIEW SOFTWARE CANNOT RECOVER THE DAP VALUE EVEN AFTER THE LINK IS RESTORED. AS A RESULT, THE DAP THAT IS PHYSICALLY SHOOTED IS MISSING FROM THE IMAGES. IT WAS CONFIRMED THAT: THE RIGHT TECHNIQUES WERE SHOOTED AND AVAILABLE TO THE USER (KVP, MAS, MA AND MS DATA), THIS DOES NOT AFFECT THE QUALITY OF THE IMAGE AS THE RIGHT DAP IS BEING SHOOTED, THERE WERE NO OVER-EXPOSURES/RE-EXPOSURES AS THE RIGHT DAP IS BEING SHOOTED, THE SYSTEM IS CURRENTLY IN USE AND THE SYSTEM HAS BEEN MONITORED AND THERE HAVE BEEN NO RE-OCCURRENCES. 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. 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 15-DEC-2025, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-COMPASS SYSTEM THAT OCCURRED ON 28-NOV-2025. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209671 DRX-COMPASS SYSTEM DRX-COMPASS SYSTEM KPR CARESTREAM HEALTH INC. 60889978624188

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other