BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABS

    MDR report key: 3175118 · Received May 31, 2013

    Report

    Report Number
    1929691-2013-00003
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    February 16, 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

    MFR IS UNABLE TO REPORT EXACT MANUFACTURING DATE AS USER FACILITY COULD NOT REPORT EXACT SERIAL NUMBER. USER FACILITY RETURNED NINE TABS MONITORS FOR EVAL. FIVE RETURNED MONITORS WERE FOUND TO NEED REPAIR OF "PAD" AND "NURSE CALL" JACKS CONSISTENT WITH NORMAL USAGE OF THE PRODUCT. AFTER REPEATED INSERTIONS AND REMOVALS OF A PAD AND/OR NURSE CALL CONNECTOR, THE PINS OF THE RJ-TYPE CONNECTORS OFTEN NEED MAINTENANCE 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, OR, AS IN THIS CASE, A MONITOR THAT ALARMS WHEN THE CONNECTOR IS PULLED AFTER PROPER ARMING. BECAUSE OF THE LARGE NUMBER OF MONITORS IN USE BY THE FACILITY, AND LACK OF RETURNS FOR MAINTENANCE, PRODUCT DISTRIBUTOR AND MANUFACTURER UNDERTOOK AN INSPECTION OF ALL TABS MONITORS AT THE FACILITY TO LOCATE ADDITIONAL MONITORS REQUIRING MAINTENANCE OR REPLACEMENT AS APPROPRIATE.

    Description of Event or Problem · 1

    FACILITY REPORTED A PRODUCT PROBLEM WITH NO INJURIES RESULTING. REPORT STATED THAT THE TABS ALARM WAS SOUNDING CONTINUOUSLY, AND WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241438 TABS BED PATIENT MONITOR KMI STANLEY SECURITY SOLUTIONS, INC. 25223 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other