BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIAL

    MDR report key: 5582446 · Received April 15, 2016

    Report

    Report Number
    1929691-2016-00001
    Event Type
    Injury
    Date Received
    April 15, 2016
    Date of Event
    March 17, 2016
    Report Date
    April 15, 2016
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC.
    Product Code
    IQA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARIAL SYSTEM AND LOG FILES WERE INSPECTED BY MANUFACTURER'S TECHNICAL SUPPORT GROUP. A DATABASE BACKUP WAS SAVED BOTH TO THE FACILITY ARIAL PC, AND IN MANUFACTURER SYSTEMS TO ALLOW FURTHER REPORTING AND INVESTIGATION AS NEEDED. ALL RELEVANT REPORTS RUN TO DATE BY MANUFACTURER HAVE BEEN SHARED WITH FACILITY. THE REPORTS INDICATE THE SYSTEM CONSISTENTLY AND REPEATEDLY SIGNALED LOW BATTERY AS EARLY AS (B)(6) 2016, ALONG WITH PENDANT ALARMS ON (B)(6) 2016. LOW BATTERY ALARMS ARE SEEN TO REPEAT NO MORE THAN 1 MINUTE AFTER EACH LOW BATTERY RESET EVENT. THE REPORTS THEN SHOW MISSING DEVICE ALARMS BEGAN ON (B)(6) 2016, WITH THE FIRST OCCURRING AT 6:37 AM RESET AT 1:06 PM, WITH THE LAST MISSING DEVICE ALARM SHOWN IN THE REPORTS BEFORE THE INCIDENT ON (B)(6) 2016 AT 10:50 PM. NO ADDITIONAL TRANSMISSIONS WERE REPORTED FOR THE MISSING DEVICE UNTIL AFTER THE INCIDENT ON (B)(6) 2016, WHEN FACILITY REPORTED BATTERY WAS CHANGED AND PENDANT WAS TESTED. A FIELD SERVICE REPRESENTATIVE (FSR) WAS ALSO DISPATCHED TO THE FACILITY ON (B)(4) 2016 TO INSPECT ADDITIONAL PENDANTS FOR SIGNS OF MOISTURE INGRESS. THE FSR INSPECTED 21 PENDANTS FROM THE SAME LOT CODE, AND NO ADDITIONAL PENDANTS WERE FOUND TO CONTAIN MOISTURE WHEN OPENED. THE PENDANTS WERE ALSO TESTED FOR TRANSMISSION FUNCTIONALITY AND PERFORMED ACCORDING TO SPECIFICATIONS. BASED ON THE ABOVE INFORMATION, IT IS UNLIKELY THAT MOISTURE IN THE PENDANT REPORTED BY FACILITY CAUSED A FAILURE OF OPERATION. REGARDLESS OF THE STATUS OF MOISTURE, THE PENDANT SIGNALED LOW BATTERY STATUS FOR A FULL WEEK BEFORE FULL DEPLETION; IF MOISTURE WERE HAVING AN EFFECT, A MUCH SHORTER TIME BETWEEN LOW BATTERY SIGNALING AND MISSING DEVICE ALARM DUE TO INTERNAL SHORTING WOULD BE EXPECTED. ADDITIONALLY, TWO PENDANT ALARMS (CALLS FOR ASSISTANCE) WERE SIGNALED DURING THE LOW BATTERY STATUS, INDICATING THAT THE DEVICE REMAINED OPERATIONAL IN ITS LOW BATTERY STATE. RATHER, REVIEW OF REPORTS FOR THE INCIDENT PENDANT SHOW LOW BATTERY FOLLOWED BY MISSING DEVICE ONE WEEK LATER, AND MEASURED VOLTAGE OF THE REPLACED BATTERY INDICATES THAT THE BATTERY HAD INSUFFICIENT CHARGE TO SIGNAL THE ARIAL SYSTEM. ADDITIONAL INSPECTION OF DEVICES FROM THE SAME LOT IN SITU DID NOT FIND OTHER PENDANTS WITH SIGNS OF MOISTURE INGRESS. DEVICE LOST ON RECEIPT AT MFR.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO MANUFACTURER THAT A RESIDENT HAD FALLEN AND SUFFERED A BROKEN HIP. ALTHOUGH THE RESIDENT WAS REPORTED TO HAVE ACTIVATED HIS PENDANT TO SIGNAL A CALL FOR ASSISTANCE, NO CALL WAS REPORTED AS RECEIVED BY THE CALL STATION. UPON FACILITY EXAMINATION OF THE DEVICE, IT WAS REPORTED THAT MOISTURE WAS FOUND INSIDE. AFTER THE MOISTURE WAS REMOVED AND BATTERY REPLACE, THE DEVICE WAS TESTED AND OPERATED NORMALLY. THE RESIDENT WAS LATER REPORTED TO HAVE UNDERGONE SURGERY AND WAS STATED TO BE RECOVERING AT A DIFFERENT FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235914 ARIAL ENVIRONMENTAL CONTROL SYSTEM, POWERED IQA STANLEY SECURITY SOLUTIONS, INC. 59350 15119

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Required Intervention