MAUDE Adverse Event Report: TIDI PRODUCTS LLC CHAIR ALARM BELT; MONITOR, BED PATIENT

Model Number	8399SL
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based solely on the information provided by the customer.Without the return of the device, the reported issue could not be confirmed.Historical data revealed similar complaints of 8399 and 8399sl alarms either sounding when they shouldn¿t or not sounding when they should.Investigations into these complaints revealed that the most likely cause of the reported complaint is either damage to the sensor receptacle or damage to the rj-11 clip.Damage can cause the pins inside the sensor receptacle to become stuck down, either triggering no alarm or false alarm.It can also cause the sensor cable to not have a secure fit in the receptacle, which can allow movement to affect function.Likewise with damage to the sensor cable clip.Other causes, such as corrosion and moisture damage, are also a possibility.A review of the device history record (dhr) of the affected lot number did not reveal any issues that could have contributed to the reported incident.Retraining was performed by the territory manager and clinical training specialist, during training it was reiterated that the patients should know how to remove the belt and not pull against it in an effort to stand up.The director of quality and risk management for the facility noted that occasionally product is being used as a positioning device, so rather than releasing the belt, patients fight against it.It was not confirmed if this was the cause for the reported issue.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 check that alarm is on and that sensor belt/alarm system is working properly each time before leaving patient unattended.Pull first yellow strap to activate alarm then connect for monitoring.Stop use at once if alarm fails to sound.Before leaving the patient unattended, explain the purpose for the belt.Make sure the patient understands: the need to call for assistance before exiting the chair; and how to self -release.Ensure all parts of the system are operational before leaving patient unattended.Currently, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.Additionally, retraining was performed with the staff at the user facility to address possible use issues.No further corrective or preventative actions are necessary at this time.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.Manufacturer reference file (b)(4).
Event or Problem Description
Customer reported 1 alarm belt 8399sl lot 5196t243 ripping as well as not connected properly to the posey sitter boxes.They are plugged into the receiver but it does not change the indicator light from yellow to green & thus never alarms when undone.Patient did have a fall but no injuries.

• Brand Name: CHAIR ALARM BELT
• Common Device Name: MONITOR, BED PATIENT
• 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: 23408798
• Report Number: 2182318-2025-00098
• Device Sequence Number: 9076553
• Product Code: KMI
• UDI-Device Identifier: 10190676007933
• UDI-Public: 10190676007933
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2025

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: 8399SL
• Device Catalogue Number: 8399SL
• Device Lot Number: 5196T243
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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