BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE PLACE

    MDR report key: 2343894 · Received November 16, 2011

    Report

    Report Number
    2343894
    Event Type
    Malfunction
    Date Received
    November 16, 2011
    Date of Event
    July 15, 2011
    Report Date
    November 11, 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

    TRANSMITTER CLIPS WOULD NOT STAY LATCHED ONCE APPLIED TO THE BABY.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 (PER SITE REPORTER).======================REPLACED OUT ALL TRANSMITTERS WITH NEW TRANSMITTERS. HAD VERBAL CONVERSATION INDICATING WE HAD RECEIVED A BAD LOT. HOWEVER, THE DESIGN HAD BEEN CHANGED BETWEEN THE ORIGINAL SET WE OBTAINED AND THE REPLACEMENT SET.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *