MAUDE Adverse Event Report: TIDI PRODUCTS LLC SITTER ON CUE PRO; FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED

Model Number	8645WL
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report is based solely on the information provided by the territory manager (tm).The tm responded to the due diligence email stating that this complaint is regarding multiple alarms with the battery door issue, and the nurse call adapters' batteries were depleting because the alarm is not working; they can't open the battery door to change them.Since they have a limited number of alarms, and it is the old firmware on these alarms, taking any from the hospital would be a disruption of service and would put patients at risk.The fall monitor battery door (m0656) is being updated to include two recessed channels to provide additional spacing/clearance from the batteries, and this design change is being addressed via moc-2023-0146.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states, test fall monitor functionality every time before each use and when leaving the patient unattended.Ensure the nurse call cable is plugged into both the fall monitor and the wall port of the nurse call system or that the wireless adapter is paired properly before leaving the patient unattended.Verify that an alert is received at the nursing station.Moreover, the wireless alarm setup guide also states, turning off the alarm unpairs the wireless chair sensor pad.Never turn off the wireless nurse call adapter or it will unpair from the alarm.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacture reference file number 2023-01385.
Event or Problem Description
A customer reported that they have experienced an increase in fall rates over the last three months due to batteries in the alarm becoming depleted.Staff stated they could not change the batteries due to the battery doors being too difficult to open.The customer also stated that fail rates have increased too due to the nurse call adapter not alerting the nurse call system.Also, they stated that they were not getting low battery notification due to not being able to replace the batteries.The customer stated that there have been multiple patient incidents.
Event or Problem Description
Supplemental medwatch being sent for corrections to a previously submitted mdr.
Additional Manufacturer Narrative
Udi related data quality updates only.This report is to correct the udi number previously reported under d4 in the original report.Manufacturer reference file (b)(4).

• Brand Name: SITTER ON CUE PRO
• Common Device Name: FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 18319957
• Report Number: 2182318-2023-00114
• Device Sequence Number: 7316568
• Product Code: PJO
• UDI-Device Identifier: 00190676007639
• UDI-Public: 00190676007639
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8645WL
• Device Catalogue Number: 8645WL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown