BEUDAMED
    FDA Adverse Event Death Summary report: N

    EASYCARE BED W/RAILS

    MDR report key: 3458756 · Received October 28, 2013

    Report

    Report Number
    3009525805-2013-00054
    Event Type
    Death
    Date Received
    October 28, 2013
    Date of Event
    October 20, 2013
    Report Date
    October 25, 2013
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOERNS SENDING THE REPORT TO THE MANUFACTURER. ADDITIONAL DEVICES: F028, SERIAL# (B)(4); INVACARE ALTERNATING PRESSURE MATTRESS, MODEL# MA55, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE FACILITY (B)(6), PER THE FACILITY THE RESIDENT WAS FOUND BY A CNA AT 3:00AM. THE RESIDENT'S LEGS WERE ON THE FLOOR, HIS HEAD WAS LAYING ON THE MATTRESS AND HIS NECK WAS RESTING ON THE ASSIST RAIL. THE FACILITY CALLED 911. THE POLICE DEPARTMENT AND PARAMEDICS ARRIVED AT THE FACILITY. THE RESIDENT WAS TRANSPORTED TO THE HOSPITAL FOR EXAMINATION BY THE CORNER. THE POLICE REPORT STATED THAT THE EVENT WAS DEATH DUE TO ACCIDENTAL POSITIONING ASPHYXIATION. THE BED AND RAILS ARE STILL IN SERVICE AT THE FACILITY AND WILL NOT BE RETURNED TO JOERNS FOR INVESTIGATION. (B)(4) WAS ENTERED INTO OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552006 EASYCARE BED W/RAILS PATIENT BED W/RAILS FNL JOERNS HEALTHCARE ECSBED

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening