BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2250753 · Received September 2, 2011

    Report

    Report Number
    2250753
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 30, 2011
    Report Date
    September 2, 2011
    Manufacturer
    HILL-ROM
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RECLINING IN BED WITH HEAD OF BED ELEVATED APPROX 45 DEGREES. PATIENT WAS ATTEMPTING UNSUCCESSFULLY TO LOWER HEAD OF BED USING HAND HELD CONTROL WITH NURSE OBSERVING PATIENT PUSHING APPROPRIATE BUTTON. NURSE VISUALLY CHECKED ELECTRIC CORD CONNECTION TO VERIFY THAT IT WAS PLUGGED INTO WALL. SUDDENLY, THERE WAS A LOUD NOISE AND THE HEAD OF THE BED DROPPED DOWN TO A FLAT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HOSPITAL BED FNL HILL-ROM * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR NO OTHER THERAPIES