BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFINIUM 8000

    MDR report key: 2963443 · Received February 13, 2013

    Report

    Report Number
    2126677-2013-00003
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    GE MEDICAL SYSTEMS LLC
    Product Code
    JAA
    PMA / PMN Number
    K051967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT WAS NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS COMPLETED, THE SYSTEM WAS EVALUATED, IT IS OPERATING PROPERLY AND NO SHARP EDGE WAS FOUND ON THE WHEEL LOCK BAR. IT WAS DETERMINED THAT THE INJURY WAS CAUSED BY THE PATIENT'S LEG TWISTING BEHIND THE WHEEL LOCK BAR. THIS WAS NOT CAUSED BY ANY MOVEMENT OR PRODUCT FAILURE OF THE FLEXI DT TABLE. AT THE HOSPITAL'S REQUEST THE GE HEALTHCARE FIELD ENGINEER REMOVED THE TWO WHEEL LOCK BAR AT THE RIGHT SIDE OF THE TABLE. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A LACERATION OF APPROXIMATELY 7-8 CM TO THE FRONT OF HIS RIGHT LOWER LEG. THE PATIENT'S LEG WENT BEHIND THE STRETCHER TABLE WHEEL LOCK BAR, DURING TRANSFER FROM A WHEELCHAIR TO THE TABLE BY THE PATIENT'S CAREGIVER. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM DEPARTMENT WHERE HE RECEIVED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63776 DEFINIUM 8000 STATIONARY X-RAY SYSTEM JAA GE MEDICAL SYSTEMS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other