BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE W/ HALF RAILS

    MDR report key: 127223 · Received October 14, 1997

    Report

    Report Number
    2182305-1997-00012
    Event Type
    Death
    Date Received
    October 14, 1997
    Date of Event
    August 6, 1997
    Report Date
    September 8, 1997
    Manufacturer
    SUNRISE MEDICAL CCG, INC.
    Product Code
    FNL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESIDENT WAS FOUND ON KNEES ALONGSIDE OF THE BED WITH UPPER TOP OF BODY LYING OVER BED WITH FACE DOWN. LEFT SIDED BODY STUCK BETWEEN BOTTOM OF HALF SIDE RAIL AND THE BED. UPPER CHEST AND HEAD WERE ON THE BED ALARM. NO PULSE OR RESPIRATION. DEATH BY ACCIDENTAL ASPHYXIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE W/ HALF RAILS SIDERAILS FNL SUNRISE MEDICAL CCG, INC. B40 W/ 1/2 RAILS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death