BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 3070226 · Received April 17, 2013

    Report

    Report Number
    1317307-2013-00003
    Event Type
    Other
    Date Received
    April 17, 2013
    Date of Event
    January 26, 2013
    Report Date
    April 17, 2013
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A WORKAROUND WAS COMMUNICATED TO PERSONNEL AT THE (B)(6) REGIONAL MEDICAL CENTER ON (B)(6 )2013. A CARESTREAM FIELD ENGINEER VISITED THE SITE AND TURNED OFF "FAST PREVIEW MODE" IN THE DETECTORS USED WITH THE SITE'S DRX-REVOLUTION MOBILE X-RAY SYSTEMS. THE DEFECT ONLY OCCURS WHEN THE DETECTOR IS BEING USED IN "LONG EXPOSURE MODE" (UP TO A 3 SECOND EXPOSURE) AND THE DETECTOR IS ALSO SET TO "FAST PREVIEW MODE." THE WORKAROUND IS TO TURN OFF FAST PREVIEW MODE, OR DO NOT USE LONG EXPOSURE MODE. THIS SOFTWARE DEFECT HAS BEEN ELIMINATED WITH DRX-1 DETECTOR FIRMWARE VERSION 99. (THE DRX-1 OR DRX-1C DETECTOR IS THE IMAGE-CAPTURE COMPONENT OF THE DRX-REVOLUTION MOBILE X-RAY SYSTEM). THIS NEW FIRMWARE VERSION WAS RELEASED ON (B)(6) 2013. THE (B)(6) REGIONAL MEDICAL CENTER'S DRX-REVOLUTION MOBILE X-RAY SYSTEMS WERE UPGRADED TO THE NEW FIRMWARE VERSION 99 ON (B)(6) 2013. THEREFORE, THE SITE WILL NO LONGER EXPERIENCE THIS ISSUE. A NEW TEST CASE WAS CREATED TO TEST FOR THIS DEFECT TO ENSURE THAT IT DOES NOT RECUR IN FUTURE SOFTWARE RELEASES.

    Description of Event or Problem · 1

    UF/ IMPORTER REPORT # 1000060000-2013-8023. DESCRIPTION: "AROUND 0445 A RETROGRADE URETHROGRAM WAS PERFORMED AT THE BEDSIDE. A RADIATION EXPOSURE WAS MADE WHILE THE CONTRAST WAS BEING PUSHED INTO THE PATIENT BY THE DR. THE IMAGE APPEARED AS THE DR. AND TECHNICIAN LOOKED AT IT CLEARLY. AFTER THE UNIT REPROCESSED, THE IMAGE WAS NON-DIAGNOSTIC. THE ALGORITHM WAS UNADJUSTABLE. EVERY ATTEMPT AT BRINGING THE IMAGE BACK WAS MADE. FINALLY, ANOTHER INJECTION OF CONTRAST WAS MADE INTO THE PATIENT AND ANOTHER IMAGE WAS TAKEN. THE PORTABLE UNIT (DR3) WAS CALLED INTO THE BIOMED. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO." CARESTREAM HEALTH WAS NOTIFIED BY THE SITE THAT AN IMAGE WAS CORRUPTED, COULD NOT BE USED FOR DIAGNOSIS, AND THAT THE PATIENT WAS RE-EXPOSED TO OBTAIN A DIAGNOSTIC IMAGE. THE ADDITIONAL DETAIL CONCERNING THE TYPE OF EXAM AND THAT A SECOND CONTRAST INJECTION WAS GIVEN TO THE PATIENT WAS NOT COMMUNICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165659 DRX-REVOLUTION MOBILE X-RAY SYSTEM SYSTEM, X-RAY, MOBILE IZL CARESTREAM HEALTH, INC. DRXR-1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR