BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 18909658 · Received March 14, 2024

    Report

    Report Number
    1317307-2024-00003
    Event Type
    Injury
    Date Received
    March 14, 2024
    Date of Event
    February 20, 2024
    Report Date
    March 14, 2024
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    UDI-DI
    60889978618897
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CARESTREAM HEALTH INC. (CSH) HAS INVESTIGATED THIS ISSUE AND IT WAS DETERMINED THAT THIS WAS DUE TO USER ERROR WHILE DRIVING THE UNIT BY PUTTING THE TECH'S BACK AGAINST A DOOR WHILE PULLING THE DEVICE TOWARDS HIM AND THROUGH THE DOOR. THIS RESULTED IN THE TECH'S LEG TO BE INJURED. CARESTREAM HAS BEEN UNABLE TO OBTAIN ADDITIONAL DETAILS REGARDING THE STATUS OF THE TECHNICIAN'S INJURY. THE CUSTOMER SITE WAS INFORMED OF THE FINDINGS AND CSH REITERATED TO FOLLOW THE INSTRUCTIONS FOR USE AND RECOMMENDED GUIDELINES FOR DRIVING THE SYSTEM. THE DRX-REVOLUTION SYSTEM WAS EVALUATED, AND IT WAS CONFIRMED THAT IT WAS FUNCTIONING AS DESIGNED AND INTENDED. THERE ARE NO FURTHER ACTIONS TO BE TAKEN BY CARESTREAM HEALTH INC. RELATED TO THIS ISSUE. THE RISK HAS BEEN MITIGATED AS FAR AS POSSIBLE. CARESTREAM HAS COMPLETED THIS INVESTIGATION.

    Description of Event or Problem · 0

    ON 20-FEB-2024, CARESTREAM HEALTH INC. (CSH) WAS INFORMED OF AN UNINTENDED MOVEMENT WHILE USING THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754641 DRX REVOLUTION MOBILE X-RAY SYSTEM DRX REVOLUTION MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH INC. 60889978618897

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other