BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODE ALERT

    MDR report key: 60918 · Received December 30, 1996

    Report

    Report Number
    60918
    Event Type
    Malfunction
    Date Received
    December 30, 1996
    Date of Event
    October 31, 1996
    Report Date
    November 5, 1996
    Manufacturer
    RF TECHNOLOGIES, INC.
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT WITH DEMENTIA AND WANDERING PROBLEM HAD CODE ALERT TRANSPONDER ON WRIST. WENT OUTSIDE TO ENCLOSED PATIO AREA BETWEEN 7:00 - 7:30 PM. THE DOOR TO THIS AREA HAD A CODE ALERT ALARM SYSTEM ON IT, BUT IT DID NOT SOUND. RESIDENT WAS FOUND LYING ON GROUND OUTSIDE (35 DEGREE F) APPROX 45-60 MINS LATER. WHEN RESIDENT'S TRANSPONDER WAS CHECKED ON OTHER DOORS IT WORKED EVERY TIME. NO PERMANENT INJURY WAS SUSTAINED - BUT IT COULD HAVE BEEN LIFE-THREATENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODE ALERT DOOR ALARM SYSTEM KMI RF TECHNOLOGIES, INC. CA2000/1 ECCHO-LOOP *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other