BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UMP

    MDR report key: 2713846 · Received August 24, 2012

    Report

    Report Number
    1929691-2012-00004
    Event Type
    Injury
    Date Received
    August 24, 2012
    Date of Event
    June 10, 2012
    Report Date
    August 6, 2012
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP WITH DISTRIBUTOR AND FACILITY INDICATED THAT THERE WAS POSSIBLY AN "AUDIO CORD" DISCONNECTED OR LOOSE AT THE TIME OF THE INCIDENT. THIS IS MOST LIKELY THE NON-STANLEY BRAND NURSE CALL SYSTEM PLUG, WHICH WAS CONNECTED TO THE UMP FALL MONITORING SYSTEM IN THIS INCIDENT. UMP MONITOR AND PAD INVOLVED IN THIS INCIDENT WERE RETURNED, TESTED, AND FOUND TO OPERATE ACCORDING TO MANUFACTURER'S SPECIFICATIONS WITH ONE EXCEPTION. ONE OF THE ALARM RESET BUTTONS WAS DAMAGED AND DID NOT OPERATE. FOLLOW-UP WITH FACILITY INDICATES THAT THIS DAMAGE WAS NOT NOTED DURING FACILITY INVESTIGATION - MOST LIKELY THIS DAMAGE OCCURRED IN SHIPPING THE UNIT TO THE MANUFACTURER. IN ANY CASE, THE ALARM RESET BUTTON WAS NOT FOUND TO AFFECT THE ALARM FUNCTIONALITY OF THE UNIT. UNIT WAS TESTED AND FOUND TO SEND ALARM SIGNALS THROUGH THE NURSE CALL OUTPUT. BASED ON REPORT FROM FACILITY AND DISTRIBUTOR, MANUFACTURER SUSPECTS THAT THE OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT. FACILITY REPORTED MOVING MONITOR FROM BED TO CHAIR MONITORING APPLICATIONS SEVERAL TIMES PER DAY. THIS LIKELY CONTRIBUTED TO THE EVENT IN THAT THE NURSE CALL PLUG AND JACK WERE DISCONNECTED OR PARTIALLY DISCONNECTED AND WOULD THEREFORE NOT TRANSMIT THE SIGNAL FROM THE FALL MONITOR TO THE NURSE CALL SYSTEM. DUE TO DAMAGE TO THE MONITOR NOTED ABOVE (NOT RELEVANT TO THIS INCIDENT AND LIKELY INCURRED IN SHIPMENT), THE MONITOR WAS REPLACED. ADDITIONAL MODEL NUMBER: 82710. ADDITIONAL LOT NUMBER: 05812 (PAD). ADDITIONAL EXPIRATION DATE: 04/11/2013 (PAD).

    Description of Event or Problem · 1

    RESIDENT AT FACILITY WAS MONITORED BY A UMP BRAND MONITOR AND BED PAD, WITH SYSTEM CONNECTED TO A NON-STANLEY BRAND NURSE CALL SYSTEM, REPORTED AS AN EARLY RESPONSE BRAND SYSTEM. FACILITY REPORTED THAT THE RESIDENT GOT UP FROM THE BED AND FELL, SUSTAINING A FRACTURED HIP. RESIDENT REQUIRED SURGERY, BUT WAS REPORTED AS RECOVERING WELL AND RETURNED TO THE FACILITY ON (B)(6) 2012. FOLLOW-UP INDICATES THAT THE UMP MONITOR WAS SET UP TO ONLY ALARM THROUGH THE NURSE CALL SYSTEM, AND WAS NOT SET TO ALARM LOCALLY AT THE MONITOR. THE FACILITY REPORTED MOVING AND RECONNECTING MONITORS SEVERAL TIMES PER DAY, AS THE SAME MONITOR WAS USED FOR BOTH BED AND CHAIR FALL MONITORING FOR A SINGLE RESIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMP UMP BED SENTEY/BED SENSOT PAD KMI STANLEY SECURITY SOLUTIONS, INC. 91621

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention