BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIAL

    MDR report key: 2192484 · Received July 14, 2011

    Report

    Report Number
    1929691-2011-00007
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 30, 2011
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIVISION
    Product Code
    ILQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) INDICATED THAT A RESIDENT HAD FALLEN IN HIS/HER BATHROOM (C3) ON (B)(6) 2011 AND THAT STAFF AT (B)(6) CLAIMED TO NOT HAVE RECEIVED PAGES ASSOCIATED WITH THE INCIDENT. (B)(4) TECHNICIANS WERE AT (B)(6) ON (B)(4) 2011 AND COULD NOT DURING ANY OF THE VISITS REPLICATE THE ISSUES AS DESCRIBED. AFTER EXTENSIVE TESTING AND REVIEW OF THE CUSTOMERS RECORDS, THE FOLLOWING WAS DETERMINED: THE SYSTEM MONITOR (COMPUTER) CLEARLY RECORDED THE INCIDENT CALL AND THE LATER "CANCEL" OF THE CALL. THE RESIDENT IN QUESTION REGISTERED 11 ALARM CALLS TO THE ARIAL SYSTEM ON THE DAY OF THE INCIDENT ((B)(6) 2011). THE AVERAGE STAFF RESPONSE TIME TO THAT RESIDENT THAT DAY WAS 8.54 MINUTES. THE LONGEST CALL INTERVAL ASIDE FROM THE INCIDENT CALL WAS 12.5 MINUTES; THE SHORTEST WAS THE FACILITY'S TEST CALL IMMEDIATELY FOLLOWING THE INCIDENT. DISREGARDING THE SHORTEST AND LONGEST CALLS, THE STAFF'S AVERAGE RESPONSE TIME TO THAT RESIDENT THAT DAY WAS 6 MINUTES. (THERE WERE ALSO THREE SAME DAY CALLS AFTER THE INCIDENT FROM THE RESIDENT'S ROOM.) DURING THE 39 MINUTE INTERVAL OF THE INCIDENT ALARM, THERE WERE 6 OTHER CALLS TO THE ARIAL SYSTEM, WHICH RESULTED IN APPROXIMATELY 30 SUCCESSFUL NOTIFICATIONS TO STAFF PAGERS (AS EVIDENCED BY THE CALL "CANCEL" TIMES ON THE SYSTEM). CORRECT OPERATION OF THE SYSTEM WAS VERIFIED BY RESPONSE TO OTHER CALLS DURING THE SAME TIME PERIOD. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(6) CONTACTED (B)(4) TECHNICAL SERVICE DEPARTMENT AND CLAIMED THAT THE ARIAL SYSTEM STOPPED DISPLAYING ROOM CALLS WHILE TESTING THEIR FIRE SYSTEM. SUBSEQUENT TO THIS CALL, A (B)(4) TECHNICIAN RESPONDED TO THE REQUEST FOR REPAIR ON (B)(6) 2011. DURING OUR TECHNICIAN'S VISIT ON (B)(4) 2011, IT WAS MENTIONED BY (B)(6) THAT HER RESIDENT HAD FALLEN IN HIS/HER BATHROOM (C3) ON (B)(6) 2011, AND THAT STAFF AT (B)(6) CLAIMED TO NOT HAVE RECEIVED PAGES ASSOCIATED WITH THE INCIDENT. ACCORDING TO THE ARIAL REPORTS AND THE INFORMATION STAFF PROVIDED, THE RESIDENT'S ARIAL WALL TRANSMITTER HAD BEEN ACTIVATED AND HAD REMAINED ACTIVE FOR 39 MINUTES STARTING AT 1:45 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIAL WALL TRANSMITTER, PAGER ILQ STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIVISION 54037 NA

    Patients

    Seq Age Sex Outcome Treatment
    1