BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODE ALERT

    MDR report key: 606280 · Received May 19, 2005

    Report

    Report Number
    606280
    Event Type
    Malfunction
    Date Received
    May 19, 2005
    Date of Event
    May 12, 2005
    Report Date
    May 19, 2005
    Manufacturer
    RF TECHNOLOGIES, INC.
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE DRILLS TO DETECT PROBLEMS WITH THE PT SECURITY SYSTEM IT WAS NOTED THAT THE TRANSMITTER FAILED TO ACTIVATE THE ALARM ON 5 FACILITY'S OF 6 ATTEMPTS. THE "STAGED" PT ABDUCTOR SUCCESSFULLY LEFT THE HOSPITAL WITH A PT AND THE PT WAS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODE ALERT INFANT SECURITY ALARM SYSTEM KMI RF TECHNOLOGIES, INC. CODE ALERT *

    Patients

    Seq Age Sex Outcome Treatment
    1 *