BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTURY BED

    MDR report key: 1616603 · Received February 18, 2010

    Report

    Report Number
    1824206-2010-02665
    Event Type
    Death
    Date Received
    February 18, 2010
    Date of Event
    January 17, 2010
    Report Date
    January 21, 2010
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT DIRECTOR OF MAINTENANCE WAS TOLD THE BED EXIT ALARM WAS SET AND THE PATIENT WAS ABLE TO GET OUT OF BED, WALK OUT OF THE FACILITY, AND WAS FOUND DECEASED NEAR AN OUT BUILDING. MAINTENANCE TESTED THE BED EXIT SYSTEM RIGHT AFTER THE INCIDENT, AND IT WAS WORKING PROPERLY. THE HILL-ROM TECHNICIAN INVESTIGATED, TESTED THE BED EXIT ALARM, AND IT IS FUNCTIONING AS DESIGNED. WHEN THE ALARM IS ACTIVATED, IT SENDS A REGULAR NURSE CALL WITH NO PRIORITY, AS THE ACCOUNT ONLY HAS A 1/4" PHONO STYLE COMMUNICATION CABLE. THE MATTRESS IS A HILL-ROM SURFACE AND IS IN GOOD WORKING ORDER.

    Description of Event or Problem · 1

    ALLEGED ON THE MORNING OF (B) (6) 2010, A PATIENT EXITED THE BED, LEFT THE HOSPITAL AND ENDED UP PASSING AWAY. THE ACCOUNT ALLEGED THAT THE BED EXIT SYSTEM WAS TURNED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURY BED AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 1400

    Patients

    Seq Age Sex Outcome Treatment
    1 Death