BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABS

    MDR report key: 3174303 · Received May 31, 2013

    Report

    Report Number
    1929691-2013-00004
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 7, 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 MANUFACTURER REPORT NUMBER 1929691-2013-0003. THE FACILITY WAS FOUND TO HAVE A NUMBER OF MONITORS REQUIRING REPAIR OF MONITOR CONNECTORS, INCLUDING THIS REPORTED MONITOR. BECAUSE OF THE LARGE NUMBER OR 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. 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 AS IN THIS CASE, OR, A MONITOR THAT ALARMS WHEN THE CONNECTOR IS PULLED AFTER PROPER ARMING.

    Description of Event or Problem · 1

    FACILITY REPORTED A PRODUCT PROBLEM WITH NO INJURIES RESULTING. REPORT STATED THAT THE TABS ALARM WAS FOUND TO HAVE A "FAULTY" CONNECTION FROM THE PAD TO THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241574 TABS BED PATIENT MONITOR KMI STANLEY SECURITY SOLUTIONS, INC. 25222 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other