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

Model Number	8399L
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported while in use on a patient, product fell apart while readjusting on patient.No patient injury was reported.
Additional Manufacturer Narrative
Visual findings observed the belt is ripped through the strap area.The rip appears clean, with no fraying, uneven tearing, or visible material weakness in adjacent areas.No abnormalities noted in surrounding stitching, loops, or seams.Velcro fasteners and loops are in good condition and show normal signs of use, with no apparent damage or detachment.Evaluation found the tear at the strap attachment appears consistent with force-related separation rather than a defect in assembly or material integrity.When the sensor was tested with an in-house alarm, the sensor passed all functional testing despite being torn in the strap area.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 ensure all parts of the system are operational before leaving the patient unattended.Failure to follow the instructions could result in serious injury.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.Additionally, the precautions section indicates that this product is a non-invasive way to monitor patient movement.This device does not prevent falls and is not a substitute for good nursing and regular visual monitoring.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.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).

• 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: 23605490
• Report Number: 2182318-2025-00101
• Device Sequence Number: 9444853
• Product Code: KMI
• UDI-Device Identifier: 10190676006288
• UDI-Public: 10190676006288
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/22/2025

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: 8399L
• Device Catalogue Number: 8399L
• Device Lot Number: 5169T140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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