BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUGS

    MDR report key: 4231945 · Received October 17, 2014

    Report

    Report Number
    1929691-2014-00002
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 17, 2014
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE IS NOT A MED DEVICE AS IT IS NOT USED TO TREAT, DIAGNOSE, CURE, OR MITIGATE A DISEASE OR CONDITION OF MAN. DEVICE IS PART OF A SECURITY SYS TO ASSIST STAFF IN PREVENTING INFANT ABDUCTION. ITEMS ARE PACKAGED IN BOXES OF (B)(4). NO SAMPLE WAS RETURNED SHOWING THE FAILURE I.E. SEPARATED STRAPS. APPROXIMATELY (B)(4) STRAPS WERE RETURNED FROM THE SUSPECT BOX AND WERE TESTED BY THE MFR. QUAL AND FUNCTIONAL TESTS WERE UNABLE TO REPRODUCE ANY FAILURE, INCLUDING STRAP INSERTION TESTS ON SAMPLE TAGS IN AN ATTEMPT TO SIMULATE USE CONDITIONS BETWEEN STRAP AND TAG RESULTING IN FAILURE. ADDITIONAL FOLLOW UP WITH FACILITY HAS NO FAR RESULTED IN NO FURTHER RESPONSE. MFR HAS REQUESTED INFO SPECIFIC TO TAGS THAT WERE IN USE WHEN STRAPS SEPARATED, TO INSPECT PRODUCTION RECORDS AND RETURN AND INSPECT ANY SUCH TAG, IF FOUND. USER FACILITY REPORT DID NOT INCLUDE PT OR DEVICE CODES. THEREFORE, MFR WAS UNABLE TO DETECT ANY FAILURE WITH RETURNED STRAPS. ALTHOUGH AWAITING FURTHER INFO FROM THE FACILITY, MFR CONCLUDES THAT THE REPORTED FAILURE TO ALARM WAS WITHIN THE FIVE MINUTES PERIOD AFTER STRAP INSERTION. PER DESIGN WHEN THE STRAP IS CUT WITHIN THE FIVE MINUTE PERIOD, THE ALARM WILL NOT SOUND. THE SYS GIVES THIS PERIOD TO NURSING STAFF TO ALLOW ADJUSTMENT TO TAG AND STRAP AFTER INITIAL INSERTION.

    Description of Event or Problem · 1

    FROM MEDWATCH FORM RECEIVED FROM USER FACILITY: "PER NURSE COORDINATOR ON PEDIATRICS: WHEN YOU PUT THE STRAP THROUGH THE HUGS TAGS, THE STRAP CURLS AND PULLS APART; AN RN PULLED THE STRAP OUT OF A HUGS TAG AND THE ALARM SHOULD HAVE GONE OFF AND IT DIDN'T; THERE WERE MULTIPLE PTS 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 ISSUES. THIS ISSUE HAS HAPPENED WITH MULTIPLE STAFF MEMBERS. CUSTOMER SERVICE CONTACTED AND SAID I COULD NOT SEND IT BACK. I HAD TO LEAVE A MESSAGE WITH QA." MFR FOLLOWED UP WITH FACILITY. STATEMENT THAT CUSTOMER COULD NOT SEND IT BACK WAS MISLEADING. MFR REQUIRED RETURN THROUGH DIST FOR RECORD-KEEPING PURPOSES. CUSTOMER RETURNED REMAINING SAMPLES THROUGH DIST, WHICH IN TURN PROCESSED A RETURN TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662462 HUGS INFANT SECURITY ILQ STANLEY SECURITY SOLUTIONS, INC. 806A2001 400082

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other