BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRIC PATIENT BED

    MDR report key: 559198 · Received November 24, 2004

    Report

    Report Number
    559198
    Event Type
    Death
    Date Received
    November 24, 2004
    Date of Event
    September 30, 2004
    Report Date
    November 24, 2004
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS FOUND ENTRAPPED BETWEEN THE AIR FLOTATION MATTRESS AND T-STYLE HALF RAIL (ON RIGHT SIDE). THE MATTRESS AND SIDERAIL WERE AT THE PATIENT'S STERNAL LEVEL AND THE LOWER EXTREMITIES WERE TOUCHING THE FLOOR.FURTHER FOLLOW UP INFORMATION REVEALS THAT AN INDEPENDENT BIOMEDICAL INVESTIGATION WAS DONE. IT IS THE OPINION THAT THIS EVENT WAS THE RESULT OF EXCESSIVE COMPRESSION OF THE AIR MATTRESS BY THE PATIENT'S WEIGHT. THIS IS RELATED TO THE DESIGN OF THE MATTRESS SECTIONS OR BAFFLES AND THE RESPONSIVENESS OF THE COMPRESSOR TO PRESSURE CHANGES OR REDISTRIBUTION OF AIR VOLUME WITHIN THE MATTRESS DUE TO CHANGES IN PATIENT POSITION. THE LACK OF MAINTENANCE OF AIR PRESSURE AT THE SIDES OF THE BED WHEN UNDER LOAD ALLOWS FULL COMPRESSION OF THE MATTRESS DOWN TO A SOLID STOP, IN THIS CASE, THE BED FRAME. ADDITIONAL FACTORS WERE THE PATIENT'S ATTEMPT TO POSSIBLY GET OUT OF BED UNASSISTED, THE SLIPPERY MATTRESS SURFACE, AND THE USE OF HALF RAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRIC PATIENT BED ELECTRIC PATIENT BED FNL INVACARE CORPORATION 53011VC *
    2 MICRO AIRE 3500S MATTRESS, INFLATABLE, AUTOMATIC FNM INVACARE CORPORATION 3500S *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death