BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 17008043 · Received May 25, 2023

    Report

    Report Number
    1317307-2023-00006
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    May 5, 2023
    Report Date
    May 23, 2023
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    UDI-DI
    60889978618897
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CARESTREAM HEALTH HAS EVALUATED THE DEVICE AND DETERMINED THERE WAS NO DEVICE MALFUNCTION, AND THE DRX REVOLUTION SYSTEM IS PERFORMING AS DESIGNED AND INTENDED. IT WAS CONFIRMED THAT THIS INCIDENT WAS DUE TO USER ERROR WHILE DRIVING THE SYSTEM WITH ONE HAND POSITIONED AT THE EDGE OF THE DRIVE HANDLE COMPRESSING THE SIDE COVERS; AT THE SAME TIME, THE OTHER HAND WAS USED TO HOLD OPEN. THE INCIDENT WAS CAUSED BY THE USER NOT FOLLOWING THE INSTRUCTIONS FOR USE (IFU). THE SITE CONTACT CONFIRMED THAT THE TECH DID NOT USE BOTH HANDS WHILE DRIVING THE DRX REVOLUTION SYSTEM. THE SERVICE PERSONNEL COMMUNICATED TO THE OPERATORS TO USE BOTH HANDS, PER THE INSTRUCTIONS FOR USE (IFU), WHILE DRIVING THE SYSTEM. THE SITE WILL ALSO RE-ENFORCE TECHS TRAINING TO NOT PUSH DRIVE HANDLE ON EDGE COMPRESSING THE SIDE COVERS. CARESTREAM HAS COMPLETED THIS INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, CARESTREAM HEALTH INC. WAS INFORMED ABOUT INCIDENT WHILE DRIVING THE DRX REVOLUTION SYSTEM. THE TECHNOLOGIST WAS ON ROUTE TO DO AN EXAM WHEN SHE REACHED TO HOLD THE AUTOMATIC DOOR OPEN WITH ONE HAND AND BACKED UP THE MOBILE WITH THE OTHER HAND. AS THE TECHNOLOGIST WAS REVERSING THE MOBILE, IT QUICKLY ACCELERATED AND PINNED HER AGAINST THE WALL. AS A RESULT, THE TECH EXPERIENCED PAIN IN HER RIGHT HIP AND SHE WAS LIMPING. SHE HAD ICE ON HER HIP AND WAS DIRECTED TO GO VISIT A DOCTOR FOR A FOLLOW UP VISIT. SHE WAS SENT HOME FOR THE DAY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1885972 DRX REVOLUTION MOBILE X-RAY SYSTEM DRX REVOLUTION MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH INC. 60889978618897

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other