BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 11033226 · Received December 17, 2020

    Report

    Report Number
    1317307-2020-00010
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    November 23, 2020
    Report Date
    December 16, 2020
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    UDI-DI
    60889971019394
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SITE REPORTED THAT WHILE OPERATING THE DRX-REVOLUTION MOBILE X-RAY SYSTEM, THE SITE LEAD TECH RAN OVER HER RIGHT FOOT, BIG TOE REQUIRING MEDICAL ATTENTION ON (B)(6) 2020. THERE WAS NO PATIENT INVOLVEMENT. CARESTREAM HEALTH HAS EVALUATED THE DEVICE AND DETERMINED THERE WAS NO DEVICE MALFUNCTION, THE SYSTEM IS PERFORMING AS DESIGNED AND INTENDED. THE INCIDENT WAS CAUSED BY THE USER NOT FOLLOWING THE INSTRUCTIONS FOR USE (IFU). THE SITE ACKNOWLEDGED AND CONFIRMED THAT THE TECH WAS POSITIONED ON THE SIDE OF THE SYSTEM, AS OPPOSED TO BEHIND THE SYSTEM, AND DID NOT USE BOTH HANDS TO DRIVE THE REVOLUTION AS SPECIFIED IN THE IFU. IT IS UNLIKELY, IF FOLLOWING THE DRIVING RECOMMENDATIONS PROVIDED WITHIN THE IFU, THAT THIS TYPE OF INJURY WOULD OCCUR. CARESTREAM HEALTH HAS CONCLUDED THIS INVESTIGATION.

    Description of Event or Problem · 1

    WHILE OPERATING THE DRX REVOLUTION SYSTEM, THE SITE LEAD TECH RAN OVER HER RIGHT FOOT, BIG TOE REQUIRING MEDICAL ATTENTION. THE RESULTING INJURY WAS A HAIR FRACTURE TO THE RIGHT FOOT, BIG TOE. THE TOE AND NAIL WERE DARK AND BRUISED. THE TECH WAS PLACED ON CHAIR DUTY TO THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496235 DRX-REVOLUTION MOBILE X-RAY SYSTEM DRX-REVOLUTION MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH INC. DRX-REVOLUTION MOBILE X-RAY SYSTEM 60889971019394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other