BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANCED CONTROL PAD SYSTEM

    MDR report key: 1025911 · Received April 4, 2008

    Report

    Report Number
    2921578-2008-00008
    Event Type
    Other
    Date Received
    April 4, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 1, 2008
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    FWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THE END-USER INAPPROPRIATELY POSITIONING THE PLACEMENT AND USING THE WRONG SIZE PADS. THEY WERE ALSO INAPPROPRIATELY POSITIONING THE PT ON THE PADS AND TABLE. IT WAS ALSO DETERMINED THAT THE HOSPITAL WAS NOT USING THE PT CARE KIT TO REDUCE ABRASIONS AND STICTION OF THE PT ON THE PADS. AN INSERVICE WITH THE HOSP HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    AFTER A THREE HR SURGERY, THE PT'S SKIN WAS BREAKING DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED CONTROL PAD SYSTEM MODULAR OPERATING ROOM TABLE SYSTEM FWY MIZUHO ORTHOPEDIC SYSTEMS, INC. 5943API

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other 5803 ADVANCED CONTROL BASE| JST SPINAL TABLE