BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX-REVOLUTION MOBILE X-RAY SYSTEM (PLUS)

    MDR report key: 14501337 · Received May 25, 2022

    Report

    Report Number
    1317307-2022-00007
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    March 23, 2022
    Report Date
    May 24, 2022
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CARESTREAM HEALTH HAS EVALUATED THE DEVICE. THE INVESTIGATION FOUND THAT THERE WERE NO DEVICE MALFUNCTIONS AND THE INCIDENT WAS CAUSED BY THE USER NOT FOLLOWING THE INSTRUCTIONS FOR USE (IFU). THE SITE CONTACT REPORTED CONFIRMED THAT THE TECH DID NOT USE BOTH HANDS, ONE HAND HOLDING OPEN A DOOR, TO DRIVE THE REVOLUTION AS SPECIFIED IN THE IFU. THERE WAS NO DEVICE MALFUNCTION. THIS WAS DUE TO USER ERROR. THE SERVICE PERSONNEL COMMUNICATED TO THE OPERATORS TO USE BOTH HANDS, PER THE INSTRUCTIONS FOR USE (IFU), WHILE DRIVING THE SYSTEM. THE SITE HAS ALSO STARTED USING RUBBER DOOR STOPS TO HOLD OPEN DOORS WHEN DRIVING THE DRX REVOLUTION THROUGH DOORWAYS TO MITIGATE THESE TYPES OF INCIDENTS. CARESTREAM HAS COMPLETED THIS INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CARESTREAM HEALTH (CSH) WAS INFORMED, VIA EMAIL, OF AN INCIDENT RELATED TO THE DRX-REVOLUTION PLUS MOBILE XRAY SYSTEM WHICH OCCURRED AT DR (B)(6) ON (B)(6) 2022. PER CARESTREAM HEALTH SERVICE PERSONNEL INVESTIGATION WHICH CONFIRMED THE FOLLOWING: THE SYSTEM IN "AS FOUND" CONDITION: NORMAL WORKING CONDITIONS WITH NO ISSUES. AT THE TIME OF THE INCIDENT, THE SYSTEM WAS BEING DRIVEN BY A SITE TECH. PER THE REPORT, THE TECH/OPERATOR WAS HOLDING A DOOR OPEN WITH ONE HAND AND ATTEMPTING TO DRIVE THE DRX REVOLUTION PLUS SYSTEM WITH THE OTHER HAND WHEN BACKING INTO THE INTENSIVE CARE UNIT AND DROVE THE SYSTEM OVER HER FOOT. THE TECH WAS ABLE TO DRIVE THE SYSTEM FORWARD OFF OF HER FOOT. THE INCIDENT RESULTED IN A TOE INJURY WHERE THE TECH LOST THE TOE NAIL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093963 DRX-REVOLUTION MOBILE X-RAY SYSTEM (PLUS) DRX-REVOLUTION MOBILE X-RAY SYSTEM (PLUS) IZL CARESTREAM HEALTH INC. 60889978618897

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other