BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH I

    MDR report key: 10494801 · Received September 4, 2020

    Report

    Report Number
    2428983-2020-00002
    Event Type
    Death
    Date Received
    September 4, 2020
    Date of Event
    August 30, 2020
    Report Date
    September 4, 2020
    Manufacturer
    GF HEALTH PRODUCTS INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    GF HEALTH PRODUCTS, INC. HAS INSPECTED THE DEVICE AT THE USER FACILITY LOCATION AND FOUND IT TO BE IN GOOD WORKING ORDER AND FUNCTIONING AS INTENDED. USER FACILITY HAS AGREED TO RELEASE THE BED TO GF HEALTH PRODUCTS, INC. FOR ADDITIONAL EVALUATION ONCE THEIR INVESTIGATION IS COMPLETE. A FOLLOW -UP REPORT WILL BE SENT IN THE EVENT THE PRODUCT SUBJECT TO THIS ADVERSE EVENT IS RELEASED AND ADDITIONAL TESTING/ANALYSIS IS PERFORMED.

    Description of Event or Problem · 1

    RESIDENT WAS FOUND ON THE FLOOR PERPENDICULAR TO THE BED FRAME IN A SUPINE POSITION WITH THE BED HAND CONTROLLER (PENDANT) UNDER HIS BODY. THE BACK OF THE RESIDENT'S HEAD WAS LOCATED ON TOP OF THE LOWER CENTER BED FRAME. THE UPPER FRAME AND SLEEP DECK LOWERED ONTO THE RESIDENTS HEAD CAUSING A LACERATION RUNNING FROM RESIDENT'S LEFT TEMPLE ACROSS THE FOREHEAD JUST ABOVE THE EYEBROWS AND ENDING AT THE RIGHT TEMPLE. ARITICULATION OF THE BED HI/LO MECHANISM WAS THE RESULT OF THE RESIDENT FALLING/SITTING/LAYING ON THE HAND CONTROLLER WHEN HE LEFT THE SLEEP SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957607 ZENITH I BED FNL GF HEALTH PRODUCTS INC. 508-1740-OL4000

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death