BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS CMAX

    MDR report key: 3253797 · Received July 25, 2013

    Report

    Report Number
    3253797
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 25, 2013
    Manufacturer
    STERIS
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN THE ORTHOPEDIC OPERATING ROOM. THE SURGEON HAD FINISHED THE OPERATION AND THEY WERE REVERSING THE ANESTHESIA EFFECTS. AT THIS POINT ONE OF THE NURSES/TECHS SMELLED SOMETHING BURNING AND REALIZED THERE WAS SMOKE COMING FROM THE BOTTOM OF THE BED. THE PATIENT (STILL INTUBATED - THEREFORE NO EXPOSURE TO THE SMOKE/FUMES) WAS TRANSFERRED TO A STRETCHER AND REMOVED FROM THE ROOM. THE OR TABLE WAS INSPECTED AND ASSESSED FOR POTENTIAL WATER DAMAGE - WATER WAS NOT FOUND. AFTER INSPECTING, IT WAS FOUND THAT THE POWER SUPPLY HAD BURNED UP AND SO HAD THE INTERNAL CABLES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SHOULDER SURGERY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348181 STERIS CMAX TABLE, OPERATING ROOM GDC STERIS CMAX 100 *
    348182 * * --- *

    Patients

    Seq Age Sex Outcome Treatment
    1 *