BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABS

    MDR report key: 3175344 · Received May 31, 2013

    Report

    Report Number
    1929691-2013-00005
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RELATED TO MFR REPORT# 1929691-2013-00003. THE FACILITY WAS FOUND TO HAVE A NUMBER OF MONITORS REQUIRING REPAIR OF MONITOR CONNECTORS. BECAUSE OF THE LARGE NUMBER OF MONITORS IN USE BY THE FACILITY, AND LACK OF RETURNS FOR MAINTENANCE, PRODUCT DISTRIBUTOR AND MFR UNDERTOOK AN INSPECTION OF ALL TABS MONITORS AT THE FACILITY TO LOCATE ADDITIONAL MONITORS REQUIRING MAINTENANCE OR REPLACEMENT AS APPROPRIATE. AFTER REPEATED INSERTIONS AND REMOVALS OF A PAD AND/OR REPLACEMENT. FACILITY WAS INSTRUCTED AS TO PROPER TESTING BEFORE EACH USE, AS PRESCRIBED IN PRODUCT USER MANUALS. USER MANUALS ALSO INSTRUCT THAT ANY PROBLEMS NOTED DURING TESTING SHOULD TRIGGER A RETURN FOR INSPECTION AND MAINTENANCE. SIGNS OF PRODUCT REQUIRING MAINTENANCE ARE A MONITOR THAT WILL NOT "ARM" FOR USAGE AS IN THIS CASE, OR, A MONITOR THAT ALARMS WHEN THE CONNECTOR IS PULLED AFTER PROPER ARMING. USER FACILITY'S DESCRIPTION OF EVENT DESCRIBES THAT THE MONITOR MAY "ARM" PROPERLY BUT EVENTUALLY FAIL TO ALARM. INSPECTION AND REVIEW OF THE FACILITY'S EQUIPMENT INDICATES THAT THIS IS INCORRECT. IF MONITOR IS PROPERLY "ARMED" WHEN PT IS PLACED IN BED, AS INDICATED BY A SHORT TONE, ANY INTERMITTENT LOSS OF CONNECTION RESULTS IN WHAT MAY BE DESCRIBED AS A "FALSE POSITIVE" ALARM.

    Description of Event or Problem · 1

    FACILITY REPORTED A PRODUCT PROBLEM WITH NO INJURIES RESULTING. REPORT STATED THAT A POTENTIAL FAILURE TO ALARM WAS IDENTIFIED AND MFR WAS INSPECTING MONITORS IN USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241804 TABS BED PATIENT MONITOR KMI STANLEY SECURITY SOLUTIONS, INC. NOT REPORTED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other