BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARIAL

    MDR report key: 2037422 · Received April 1, 2011

    Report

    Report Number
    1929691-2011-00001
    Event Type
    Death
    Date Received
    April 1, 2011
    Date of Event
    February 26, 2011
    Report Date
    March 23, 2011
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIV.
    Product Code
    ILQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL #: 54037. ON (B)(4) 2011, A STANLEY SECURITY SOLUTIONS FIELD SERVICE TECHNICIAN ARRIVED AT (B)(6) TO EVALUATE THE ARIAL DIALER PANELS AND ARIAL WALL TRANSMITTERS. DURING THE TECHNICIAN'S VISIT IT WAS REPORTED ALL 4 ARIAL DIALER PANELS PASSED THE SYSTEM TEST. THIS INDICATED THAT ALL SIGNALS FROM THE ARIAL WALL TRANSMITTERS IN APARTMENT (B)(6) FUNCTIONED PROPERLY, AND WOULD SUCCESSFULLY SEND ALARMS TO THE DIALER PANEL. SYSTEM TESTING VERIFIED CORRECT OPERATION. CORRECT OPERATION OF THE ARIAL WALL TRANSMITTER AND ARIAL DIALER PANEL WAS ALSO VERIFIED BY THE ACCOUNT ACTIVITY. WHEN THE FAMILY MEMBER FOUND THE RESIDENT, AN ALARM SIGNAL WAS SENT AT 8:24 A.M. FROM ROOM (B)(6). ON (B)(4) 2011, (B)(6) (DIRECTOR OF MAINTENANCE) INDICATED THAT THE RESIDENT DID NOT SET THE WALL TRANSMITTER INTO ALARM, THEREFORE IN THIS SITUATION NO ALARM COULD HAVE BEEN SENT TO THE (B)(4) OR 3RD PARTY CALL CENTER AT THE TIME OF THE ACTUAL INCIDENT. FURTHERMORE, (B)(6) INDICATED THAT SYSTEM TESTING IS NOT CONDUCTED AT THE FACILITY. THE FIELD TECHNICIAN INDICATED TO (B)(6) THAT REGULAR TESTING SHOULD BE CONDUCTED AT THE (B)(6) TO ENSURE THAT THE 3RD PARTY CALL CENTER RECEIVES THE ALARMS AND THAT ALARMS ARE ACCURATELY REPORTED BY THE CALL CENTER. TECHNICIAN INDICATED TO THE FACILITY THAT TESTING RESULTS SHALL BE DOCUMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT A RESIDENT WAS FOUND DECEASED BY A FAMILY MEMBER AT APPROXIMATELY 9:30 AM EASTERN TIME ON (B)(6)-2011. IT WAS FURTHER INDICATED BY THE DIRECTOR OF MAINTENANCE, (B)(6), THAT THE RESIDENT WAS FOUND ON THE LIVING ROOM FLOOR, ACROSS THE ROOM FROM THE ARIAL WALL TRANSMITTER. IT WAS REPORTED THAT NO ALARM SIGNAL WAS RECEIVED AT THE ARIAL DIALER PANEL FROM THE ARIAL WALL TRANSMITTER IN APT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIAL DIALER PANEL AND WALL TRANSMITTER ILQ STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIV. 54007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1