MAUDE Adverse Event Report: STANLEY SECURITY SOLUTIONS, INC. ARIAL; ENVIRONMENTAL CONTROL SYSTEM, POWERED

Model Number 59350

Device Problems Use of Device Problem (1670); Low Battery (2584)

Patient Problem Fall (1848)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ARIAL
• Type of Device: ENVIRONMENTAL CONTROL SYSTEM, POWERED
• Manufacturer (Section D): STANLEY SECURITY SOLUTIONS, INC.; 4600 vine street; lincoln NE 68503
• Manufacturer (Section G): STANLEY SECURITY SOLUTIONS, INC.; 4600 vine street; lincoln NE 68503
• Manufacturer Contact: gina bennett ; 4600 vine street; lincoln, NE 68503 ; 4072712097
• MDR Report Key: 5582446
• MDR Text Key: 42850977
• Report Number: 1929691-2016-00001
• Device Sequence Number: 1
• Product Code: IQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 59350
• Device Catalogue Number: 59350
• Device Lot Number: 15119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 98 YR