BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA XR220AMX

    MDR report key: 3022749 · Received March 22, 2013

    Report

    Report Number
    2126677-2013-00007
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 22, 2013
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZL
    PMA / PMN Number
    K103476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S EMPLOYEE SEX AND WEIGHT WERE NOT PROVIDED. INITIAL REPORTER OCCUPATION WAS NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A GE HEALTHCARE'S EMPLOYEE WAS POSITIONING THE OPTIMA XR220 X-RAY MOBILE DEVICE AT A HOSPITAL, AND WHEN THEY SELECTED REVERSE MOTION, THE GE HEALTHCARE EMPLOYEE WAS PUSHED BACK INTO A SURGICAL METAL TABLE AND THE LEFT REAR WHEEL CONTACTED THEIR LEFT SHOE. AS A RESULT OF THE IMPACT WITH THE EMPLOYEE'S FOOT, THERE WAS REDNESS AND SLIGHT BRUISING. UPON BEING SEEN BY A DOCTOR, AN X-RAY WAS TAKEN BUT WAS NEGATIVE FOR ANY FRACTURES. THE GE HEALTHCARE EMPLOYEE WAS ALSO DIAGNOSED WITH CELLULITIS AND TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119115 OPTIMA XR220AMX SYSTEM, X-RAY, MOBILE IZL GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other