BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE BED/F-1401 RAIL

    MDR report key: 635536 · Received July 9, 2005

    Report

    Report Number
    635536
    Event Type
    Death
    Date Received
    July 9, 2005
    Date of Event
    June 20, 2005
    Report Date
    July 8, 2005
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS CHECKED AT APPROX. 2:45 A.M. BY HST (CERTIFIED NURSING ASSISTANT). RESIDENT WAS LAYING IN THE MIDDLE OF THE BED ON THEIR BACK. STAFF DISCOVERED RESIDENT AT 5:30AM ROUNDS. RESIDENTS HEAD AND NECK BETWEEN THE MATTRESS AND SIDE RAIL REST OF BODY KNEELING ON FLOOR TOWARD BED, KNEES IN MAT BY BED ARMS DOWN FLAT. FAMILY INSISTED ON USE OF SIDE RAIL FOR RESIDENT FOR POSITIONING IN BED. FAMILY SIGNED CONSENT FOR USE OF SIDE RAILS. FACILITY INTERVENTIONS INCLUDED PERIMETER MATTRESS ON BED, A TABS ALARM, BOLSTER BETWEEN MATTRESS AND SIDERAIL, LOW BED AND SAFETY MAT ON FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BED/F-1401 RAIL HOSPITAL BED 1/2 RAIL FNJ SUNRISE MEDICAL B-40/F1401 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death