BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFE PLACE PATIENT WANDERING

    MDR report key: 877178 · Received July 9, 2007

    Report

    Report Number
    MW5002980
    Event Type
    Injury
    Date Received
    July 9, 2007
    Date of Event
    May 20, 2007
    Report Date
    June 25, 2007
    Manufacturer
    RF TECHNOLOGIES, INC
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NURSING HOME RESIDENT TAGGED WITH AN ALARM DEVICE PASSED THROUGH 2 DOORS WHICH WERE EQUIPPED TO DETECT THE ALARM DEVICE; THE RESIDENT EXITED THE BUILDING UNDETECTED BECAUSE OF EQUIPMENT FAILURE. THE SAME RESIDENT WENT THROUGH THE SAME TWO ALARMED DOORS, UNDETECTED BECAUSE OF EQUIPMENT FAILURE. RFT WANDERGUARD SYSTEM WAS INSTALLED IN SENIOR HAVEN NURSING HOME TO LET US KNOW WHEN RESIDENTS IDENTIFIED AS AT-RISK FOR ELOPEMENT WERE ATTEMPTING TO EXIT THE BUILDING. IDENTIFIED RESIDENTS WEAR AN ANKLET OR BRACELET SENSOR: BAND UNIT WHICH CAUSES AN ALARM TO SOUND WHEN THE TAGGED RESIDENT PASSES THROUGH A DOOR EQUIPPED TO DETECT THE SENSORS. UNDETECTED ELOPEMENT CAN BE LIFE-THREATENING TO COGNITIVITY IMPAIRED RESIDENTS. WANDERGUARD MFR WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE PLACE PATIENT WANDERING PATIENT CARE TRANSMITTERS AND BANDING MATERIAL KMI RF TECHNOLOGIES, INC 9450-4262

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening