BEUDAMED
    FDA Adverse Event Summary report: N

    TABS MOBILITY MONITOR

    MDR report key: 1246783 · Received November 21, 2008

    Report

    Report Number
    1246783
    Date Received
    November 21, 2008
    Date of Event
    November 21, 2008
    Report Date
    November 21, 2008
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BED ALARM IN PLACE. PATIENT FELL OUT OF BED AND ALARM DID NOT SOUND. WHEN TESTED LATER BY STAFF, THE RECORDED MESSAGE VOICE WAS ACTIVATED, BUT THE WARNING ALARM DID NOT SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TABS MOBILITY MONITOR ALARM, BED, HOSPITAL KMI STANLEY SECURITY SOLUTIONS, INC. 25223 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR