BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANA OPERATING ROOM TABLE

    MDR report key: 3232345 · Received October 31, 2012

    Report

    Report Number
    2921578-2012-00019
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 3, 2012
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON FINISHING A ROUTINE INTERTROCHANTERIC FRACTURE REPAIR (RIGHT LEG), THE STAFF TRIED TO TRANSFER A PATIENT FROM THE HANA TABLE TO THE STRETCHER. ALL DRAPES AND IOBAN WAS REMOVED AND PATIENT WAS SEWN UP AFTER THE PROCEDURE. THE TRANSFER BOARD WAS NOT IN PLACE. BOTH FEET WERE STILL IN BOOTS WHICH WERE ATTACHED TO THE SPARS. THE NURSE AT THE END OF THE TABLE, REACHED IN TO PULL THE PERINEAL POST. IT WAS VERY HARD TO PULL OUT AND WHEN IT DID COME OUT, THE PATIENT WHICH WAS NOT CENTERED ON THE PERINEAL POST, FELL OFF OF THE BED TO THE RIGHT SIDE. THERE WAS A NURSE THERE TO CATCH HIM BUT THE PATIENT STILL ENDED UP ON THE FLOOR. THE STRETCHER WAS CLOSE TO THE TABLE ON THE LEFT SIDE BUT THERE WAS A TECH BETWEEN THE STRETCHER AND HANA TABLE. THERE WAS NO SAFETY BELT USED DURING THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANA OPERATING ROOM TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 6875 6875

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention