BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABS BED ALARM

    MDR report key: 3049507 · Received February 21, 2013

    Report

    Report Number
    3049507
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 21, 2013
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS FOUND ON FLOOR OF ROOM. WHEN STAFF ENTERED ROOM THERE WAS NO ALARM SOUNDING. TABS BED ALARM WAS HOOKED UP PROPERLY, BUT NOT SOUNDING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THE ALARM TO SOUND WHEN WHEN PATIENT ATTEMPTS TO GET UP.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75717 TABS BED ALARM ALARM KMI STANLEY SECURITY SOLUTIONS, INC. 25222 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR