BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE PLACE INFANT SECURITY

    MDR report key: 2344911 · Received November 16, 2011

    Report

    Report Number
    2344911
    Event Type
    Malfunction
    Date Received
    November 16, 2011
    Date of Event
    July 15, 2011
    Report Date
    November 16, 2011
    Manufacturer
    RF TECHNOLOGIES, INC
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    SYSTEM ALARMING FREQUENTLY. PER MANUFACTURER, IT IS EXPECTED BUT THIS WAS NOT DISCLOSED OR EDUCATED TO FACILITY PRIOR TO OR AT THE TIME OF PURCHASE. EVEN AFTER MULTIPLE REQUESTS FOR REFERENCES FROM OTHER HOSPITALS ON THIS PRODUCT, THE COMPANY HAS NOT PRODUCED ANY WITH MULTIPLE REASONS AS TO WHY THEY CAN NOT.======================MANUFACTURER RESPONSE FOR INFANT/CHILD SECURITY ALARM, SAFE PLACE INFANT SECURITY (PER SITE REPORTER).======================MANUFACTURER REPORTED TO FACILITY THAT WE CAN EXPECT AN AVERAGE OF UP TO 1 ALARM PER BABY PER STAY. COMPANY HAS ADJUSTED SOME OF THE CONFIGURATION SETTINGS TO HELP WITH THE CONTINUOUS ALARMING. EDUCATOR SENT IN TO RE-INSERVICE STAFF ON HOW TO PROPERLY PLACE THE BAND ON THE BABIES TO TRY AND HELP CONTROL THE ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE PLACE INFANT SECURITY INFANT/CHILD SECURITY ALARM KMI RF TECHNOLOGIES, INC 9450 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *