BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE BED WITH SIDERAILS

    MDR report key: 127227 · Received October 14, 1997

    Report

    Report Number
    2182305-1997-00011
    Event Type
    Death
    Date Received
    October 14, 1997
    Date of Event
    July 9, 1997
    Report Date
    July 28, 1997
    Manufacturer
    SUNRISE MEDICAL CCG, INC.
    Product Code
    FNJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESIDENT IN BED, RAILS IN THE UP POSITION, RESIDENT ALERT AND ORIENTED, BUT NOT MOBILE. SHE WAS FOUND LYING WITH HER CHIN ON LOWER PART OF SIDE RAIL AND LOWER PART OF SIDE RAIL AND LOWER POSITION OF BODY WAS RESTING ON FLOOR. THERE WERE NO VITAL SIGNS. AUTOPSY WAS REQUEST, SHOULD GET REPORT WITHIN 8 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BED WITH SIDERAILS SIDERAILS FNJ SUNRISE MEDICAL CCG, INC. B4030ML W/F1141 RAILS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death