BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 3955824 · Received June 25, 2014

    Report

    Report Number
    1317307-2014-00010
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 24, 2014
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNOLOGIST WAS OPERATING IN A CONFINED SPACE. WHILE STANDING BEHIND THE UNIT, THE TECHNOLOGIST ATTEMPTED TO MOVE BACKWARD, AND ALLEGES THE UNIT JERKED AND RAN OVER HER FOOT. NO INJURY REPORTED. BASED ON THE DEVICE EVALUATION, THE DEVICE IS MEETING SPECIFICATIONS HOWEVER, CARESTREAM HEALTH IS CONTINUING TO INVESTIGATE THIS INCIDENT.

    Description of Event or Problem · 1

    TECHNOLOGIST ALLEGES THAT REVOLUTION JERKED BACKWARDS AND RAN OVER A TOE ON HER LEFT FOOT. THE TECHNOLOGIST DID NOT WANT MEDICAL ATTENTION AND THEREFORE, THERE IS NO INJURY ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370348 DRX REVOLUTION MOBILE X-RAY SYSTEM DRX REVOLUTION IZL CARESTREAM HEALTH, INC. DRXR-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA