BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANCE BED

    MDR report key: 3000938 · Received March 6, 2013

    Report

    Report Number
    1824206-2013-01251
    Event Type
    Death
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 7, 2013
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED THE ALLEGED INCIDENT AND THE ACCOUNT STATED THAT THE BED WAS IN GOOD WORKING CONDITION. THE TECHNICIAN PERFORMED AN OPERATIONAL TEST FOR SIDE RAILS, BRAKES AND ALL CONTROLS AND ALL FUNCTIONS OPERATED AS DESIGNED. THE TECHNICIAN STATED THAT THE BED WAS EQUIPPED WITH Z-INSERTS IN THE SIDE RAILS. THE BED WAS NOT EQUIPPED WITH THE FULL HBSW SIDE RAILS. THE MATTRESS WAS FOAM HILL-ROM MATTRESS W/O WORDING.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT A PT WAS FOUND ON THE FLOOR WITH THEIR HEAD WEDGED BETWEEN THE RIGHT HEAD SIDE RAIL AND THE MATTRESS. WHEN THE PT WAS FOUND THEY WERE UNRESPONSIVE AND ATTEMPTS TO REVIVE THE PT FAILED, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95546 ADVANCE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1105

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death