BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VRT TABLE W/INTEGRATING TUBE STAND/ELEV

    MDR report key: 4892385 · Received July 6, 2015

    Report

    Report Number
    2126677-2015-00011
    Event Type
    Injury
    Date Received
    July 6, 2015
    Date of Event
    October 21, 2014
    Report Date
    October 29, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    K813173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION CONCLUDED THAT THE CAUSE OF THE EVENT WAS DETERMINED TO BE USE ERROR. THE TABLE IS NOT DESIGNED FOR A PATIENT TO STAND ON THE TABLE.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. ADDITIONAL MANUFACTURER NARRATIVE: 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 DURING A FOOT EXAM WITH A PATIENT STANDING ON THE X-RAY TABLE, THE PATIENT STUMBLED AND FELL TO THE FLOOR. THE PATIENT RECEIVED A BROKEN ARM AS A RESULT OF THE FALL TO THE FLOOR AND WAS TREATED AT THE HOSPITALS EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435083 VRT TABLE W/INTEGRATING TUBE STAND/ELEV SYSTEM, X-RAY, STATIONARY KPR GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other