BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPIRIT ONE

    MDR report key: 4543692 · Received January 28, 2015

    Report

    Report Number
    1831750-2015-00054
    Event Type
    Death
    Date Received
    January 28, 2015
    Date of Event
    January 1, 2015
    Report Date
    January 5, 2015
    Manufacturer
    CHG HOSPITAL BEDS, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE WENT TO THE PT ROOM TO CHECK ON THE PT. THE PT WAS ALLEGEDLY FOUND DECEASED, KNEELING ON THE FLOOR, WITH HIS HEAD BETWEEN THE LEFT HEADEND AND FOOTEND SIDERAILS. THE USER FACILITY FURTHER REPORTED THAT THE PT, WHO WAS ADMITTED FOR "BEHAVIORAL ISSUES," WAS AMBULATORY AND WAS GIVEN THE FREEDOM TO GET OUT OF BED AND WALK AROUND. THE UNIT INVOLVED IN THE REPORTED INCIDENT WAS EVALUATED BY THE MFR, AND NO MALFUNCTION OR DEFECTS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63899 SPIRIT ONE BED, AC-POWERED ADJUSTABLE HOSP FNL CHG HOSPITAL BEDS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death