BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAFE-T CARE INCLOSURE SYSTEM

    MDR report key: 741138 · Received July 20, 2006

    Report

    Report Number
    741138
    Event Type
    Death
    Date Received
    July 20, 2006
    Date of Event
    June 27, 2006
    Report Date
    July 20, 2006
    Manufacturer
    SAFE-T CARE MANUFACTUIRNG, INC.
    Product Code
    FNJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ENCLOSURE BED WAS USED FOR THE SAFETY OF A PT WITH HYPOXIC ENCEPHALOPATHY. FIVE DAYS LATER, AN AIR MATTRESS FOR SKIN CARE WAS PLACED ON THE BED WITH THE ENCLOSURE APPRATUS. THE SIDE RAILS WERE NOT IN THE "UP" POSITION (CONCLUSION FROM OUR INVESTIGATION). THERE WAS EXCESS MATERIAL (FOR THE ARTICULATION OF THE HEAD OF THE BED) BETWEEN THE AIR MATRESS AND THE ENCLOSURE BED CAUSING A GAP. IT IS THIS PART OF THE BED WHERE THE PT'S HEAD WAS CAUGHT. THE PT WAS FOUND UNRESPONSIVE, A CODE WAS CALLED. THE PT WAS TRANSFERRED TO ICU WHERE SHE EXPIRED IN 2006. A SPACING HOLSTER DESCRIBED IN THE ENCLOSURE BED INSTRUCTIONS OBTAINED AFTER THE EVENT WAS NOT PROVIDED BY THE BED CO SUPPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE-T CARE INCLOSURE SYSTEM ENCLOSURE BED FNJ SAFE-T CARE MANUFACTUIRNG, INC. MODEL HD *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death