BEUDAMED
    FDA Adverse Event Death Summary report: N

    EASYCARE BED

    MDR report key: 5267874 · Received December 4, 2015

    Report

    Report Number
    3009402404-2015-00036
    Event Type
    Death
    Date Received
    December 4, 2015
    Date of Event
    November 16, 2015
    Report Date
    December 4, 2015
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EQUIPMENT: F14SCAL RAILS ON THE BED, SERIAL#'S (B)(4), MANUFACTURED BY JOERNS HEALTHCARE, DATE OF MANUFACTURER IS 12/08/2011. THE AIR MATTRESS INVOLVED IS MANUFACTURED BY (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER CNA WAS MAKING ROUNDS AND WITNESSED THE RESIDENT HALF WAY ON THE FLOOR WITH HER HEAD POSSIBLE STUCK BETWEEN SIDE RAIL AND AIR MATTRESS. THE PATIENTS' TOP HALF OF HER BODY WAS ON THE BED AND LOWER HALF WAS ON THE FLOOR. BED WAS IN THE LOWEST POSITION. EMS WAS CALLED AND PROVIDED SUPPORTIVE CARE UNTIL A DNR WAS COMPLETED. A BED ASSESSMENT WAS NOT PERFORMED FOR THIS PATIENT PRIOR TO USING THE BED, RAILS OR AIR MATTRESS. ON (B)(6) 015, A JOERNS ASSOCIATE VISITED THE FACILITY AND TESTED THE BED AND RAILS. THE BED AND RAILS ARE OPERATING IN GOOD SHAPE AND ARE IN-SERVICE WITH ANOTHER RESIDENT SINCE INCIDENT. COMPLAINT# (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797065 EASYCARE BED ELECTRIC PATIENT BED FNL JOERNS HEALTHCARE EASYCARE 5

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death