BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARIAL

    MDR report key: 2648247 · Received July 9, 2012

    Report

    Report Number
    1929691-2012-00001
    Event Type
    Death
    Date Received
    July 9, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 29, 2012
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    ILQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER MADE CONTACT WITH FACILITY BY PHONE ON (B)(6) 2012 TO GATHER DETAILS OF INCIDENT. FACILITY REPORTED THAT HEALTHCARE STAFF RECEIVED THE CALL TO THEIR PAGERS AND CHECKED ROOM 122 - RATHER THAN ROOM 22, WHICH WAS THE ACTUAL SOURCE OF THE CALL. FACILITY STAFF FOUND THE RESIDENT ON THE FLOOR APPROXIMATELY 40 MINUTES AFTER THE INITIAL CALL RECEIVED BY THE ARIAL SYSTEM, AS SHOWN BY A REVIEW OF SYSTEM LOGS. MANUFACTURER'S STAFF ALSO VISITED THE FACILITY ON (B)(4) 2012. A REVIEW OF SYSTEM SETTINGS AND SYSTEM LOGS WAS CONDUCTED AND ALL ARIAL CALL POINTS WERE CHECKED TO CONFIRM THAT CALL POINTS WERE SET UP TO PAGE STAFF IN THE CORRECT AREAS. ADDITIONALLY, MANUFACTURER'S STAFF MANUALLY CHECKED ALL STATIONARY CALL POINTS TO CHECK THAT SIGNALS WERE TRANSMITTED AND PROPER STAFF PAGERS RECEIVED THOSE SIGNALS. FACILITY UNDERTOOK A FURTHER CHECK OF ALL PENDANT TRANSMITTERS (I.E. NON-STATIONARY TRANSMITTERS) TO CHECK THAT SIGNALS WERE TRANSMITTED AND PROPER STAFF PAGERS RECEIVED THOSE SIGNALS. THE DEVICE IN USE AT THE TIME OF THIS EVENT WAS EVALUATED ONSITE BY MANUFACTURER'S STAFF. NO DEVICE MALFUNCTION WAS FOUND, AND FURTHER DEVICE EVALUATION WAS DETERMINED TO BE UNNECESSARY. OPERATIONAL SETTINGS OF THE SYSTEM WERE SUCH THAT THE SIGNAL WAS RECEIVED AT AND TRANSMITTED BY THE ARIAL SYSTEM; HOWEVER, THE INCORRECT GROUP OF STAFF PAGERS WAS CONFIGURED TO RECEIVE CALLS FROM THE TRANSMITTER IN USE AT THE TIME OF THIS EVENT. MANUFACTURER'S STAFF CONFIRMED CONFIGURATION OF PAGER SETTINGS ON ALL CALL DEVICES IN USE AT THE FACILITY DURING FACILITY VISIT (B)(4) 2012, AND CONFIRMED VIA FOLLOW-UP PHONE CALL ON (B)(6) 2012 THAT STAFF HAD COMPLETED MANUAL TESTING OF ALL NON-STATIONARY CALL POINTS AFTER FACILITY VISIT ON (B)(4) 2012.

    Description of Event or Problem · 1

    RESIDENT IN ASSISTED LIVING FACILITY FELL AND SUSTAINED A BROKEN HIP. RESIDENT SIGNALED FOR ASSISTANCE VIA THE ARIAL CALL SYSTEM PULL CORD STATION IN BATH. SIGNAL WAS TRANSMITTED TO THE ARIAL SYSTEM BUT PAGING SIGNAL WAS SENT TO HEALTHCARE STAFF PAGERS RATHER THAN ASSISTED LIVING STAFF PAGERS IN THE FACILITY. RESIDENT UNDERWENT SURGERY THE FOLLOWING DAY TO REPAIR HER BROKEN HIP WITHOUT INCIDENT, THEN LATER THE SAME EVENING SUFFERED HEART AND RENAL FAILURE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIAL ARIAL NURSE CALL SYSTEM ILQ STANLEY SECURITY SOLUTIONS, INC. 54336 NOT NEEDED

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death