BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVOLUTION XR/D

    MDR report key: 2181180 · Received July 21, 2011

    Report

    Report Number
    2126677-2011-00117
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    March 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    K012389
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SUPPORTING THE PT, A HAND REST SLIPPED OFF THE END OF THE REVOLUTION XR/D TABLE CAUSING THE PT TO MOVE SUDDENLY OUT OF POSITION. THE PT SOUGHT FOLLOW UP MEDICAL ASSISTANCE FROM HER FAMILY DOCTOR WHO DIAGNOSED BACK AND NECK SOFT-TISSUE STRAIN AND PRESCRIBED PHYSIOTHERAPY AND MEDICATION. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION XR/D STATIONARY X-RAY SYSTEM KPR GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention