BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOSPITAL BED AND HILL ROM AIR MATTRESS

    MDR report key: 1445133 · Received August 19, 2009

    Report

    Report Number
    2182305-2009-00029
    Event Type
    Death
    Date Received
    August 19, 2009
    Date of Event
    July 18, 2009
    Report Date
    August 14, 2009
    Manufacturer
    JOERNS HEALTHCARE INC. FOR BED
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER, BY FACILITY, PER FACILITY IN THE EARLY MORNING, THEY FOUND A FEMALE RESIDENT EXPIRED. CLAIMING THAT THE BED WAS IN ITS LOW POSITION, HER LOWER BODY WAS LYING ON THE FLOOR WITH HER NECK AND HEAD AGAINST SIDERAIL. PRELIMINARY AUTOPSY FINDINGS: PRIMARY CAUSE OF DEATH ASSOCIATED WITH ASPHYXIATION ENTRAPMENT, SECONDARY HEART DISEASE. ALL EQUIPMENT WAS IN WORKING ORDER. FACILITY WAS USING A HILL ROM PW-50 AIR MATTRESS WITH OUR U795 BED AND F17TM 1/2 RAILS. AS DESCRIBED THIS WOULD BE CONSIDERED AS A ZONE 3: BETWEEN THE RAIL AND THE MATTRESS ENTRAPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPITAL BED AND HILL ROM AIR MATTRESS BED, HOSPITAL ELECTRIC & HILL ROM AIR MATTRESS FNL JOERNS HEALTHCARE INC. FOR BED U795 W/ F17TM 1/2 RAILS

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death