BEUDAMED
    FDA Adverse Event Death Summary report: N

    BED, HOSPITAL

    MDR report key: 954660 · Received November 27, 2007

    Report

    Report Number
    2182305-2007-00036
    Event Type
    Death
    Date Received
    November 27, 2007
    Date of Event
    June 22, 2005
    Report Date
    September 28, 2007
    Manufacturer
    JOERNS HEALTHCARE, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER, BY ATTORNEY, A NOTICE OF WRONGFUL DEATH WAS SERVED IN 2007. "PER CLAIM, THE DECEDENT BECAME LODGED BETWEEN HIS BED MATTRESS AND HIS BED RAILS AND AS A RESULT OF HAVING BECOME SO LODGED WAS UNABLE TO BREATH AND DIED AS A RESULT OF POSITIONAL ASPHYXIATION". IT APPEARS THAT THE PRODUCT (BED, RAILS, AND MATTRESS) WAS NOT PRESERVED BY THE NURSING HOME AND AS A RESULT OF THAT ACTION WE CAN NOT IDENTIFY FOR CERTAIN THAT THE PRODUCT IN QUESTION WAS MANUFACTURED BY JOERNS HEALTHCARE INC. HOWEVER, OUR RECORDS DO INDICATE THAT CUSTOMER/EVERGREEN NURSING AND REHABILITATION CENTER HAS ORDERED FROM US AS WELL AS THROUGH CATALOG SUPPLIER/DIRECT SUPPLY OUR CUSTOMER. AND THOSE RECORDS SHOW FACILITY HAS PURCHASED THE MODEL EZC B684 BED AND F14 1/2 SIDE RAILS. REPORT IS STILL IN THE DISCOVERY STAGE. AS DESCRIBED, THIS WOULD BE CONSIDERED A ZONE 3; BETWEEN THE RAIL AND MATTRESS ENTRAPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED, HOSPITAL BED, HOSPITAL, ELECTRIC FNL JOERNS HEALTHCARE, INC. B684 W/F14 1/2 RAILS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death