BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUGS INFANT PROTECTION

    MDR report key: 4095174 · Received September 16, 2014

    Report

    Report Number
    4095174
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PER NURSE COORDINATOR ON PEDIATRICS: 1. WHEN YOU PUT THE STRAP THROUGH THE HUGS TAG, THE STRAP CURLS AND PULLS APART. 2. AN RN PULLED THE STRAP OUT OF A HUGS TAG AND THE ALARM SHOULD HAVE GONE OFF AND IT DIDN'T.3. THERE WERE MULTIPLE PATIENTS THAT THIS HAPPENED TO. ALSO THERE WERE SOME FROM DEVICES IN THIS BOX OF STRAPS THAT WORKED FINE.THE UNIT HAS BEEN USING ANOTHER BOX OF STRAPS WITH THE SAME NUMBER THAT IS STAMPED ON THE END OF THE BOX FOR TWO DAYS AND HAVE HAD NO ISSES. THIS ISSUES HAVE HAPPENED WITH MULTIPLE STAFF MEMBERS. CUSTOMER SERVICE CONTACTED AND SAID I COULD NOT SEND IT BACK. ====================== MANUFACTURER RESPONSE FOR INFANT SECURITY STRAP FOR THE HUGS TAGS, HUGS INFANT PROTECTION (PER SITE REPORTER)======================I HAD TO LEAVE A MESSAGE WITH QA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572137 HUGS INFANT PROTECTION MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O ILQ STANLEY SECURITY SOLUTIONS, INC * 400082

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY HUGS TAG THAT THE STRAP GOES INTO.