BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 3767227 · Received April 1, 2014

    Report

    Report Number
    1317307-2014-00003
    Event Type
    Injury
    Date Received
    April 1, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 31, 2014
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE FIELD ENGINEER'S EVALUATION OF THE EQUIPMENT AT THE CUSTOMER SITE, THE DEVICE WAS PERFORMING TO SPECIFICATION. THIS ISSUE IS RELATED TO USER ERROR WHERE CARESTREAM BELIEVES THE USER MAY NOT HAVE BEEN USING THE DEVICE ACCORDING TO THE INSTRUCTIONS.

    Description of Event or Problem · 1

    A REVOLUTION SYSTEM LURCHED BACKWARDS WHEN THE TECHNICIAN WAS TRYING TO GO FORWARD AND IT RAN OVER THE TECHNICIAN'S FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196232 DRX REVOLUTION MOBILE X-RAY SYSTEM DRX REVOLUTION IZL CARESTREAM HEALTH, INC. DRXR-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA