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

Model Number	8399
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported product is failing while in use with the patient and concerned that more may fail and cause injuries.No patient injury was reported for this event.
Additional Manufacturer Narrative
Product was not returned for this event with serial number (b)(6) but was returned for product under manufacturer file (b)(4) serial number (b)(6).In this event, visual findings observed the belt was ripped through the strap area and the foam section where one strap is sewn has torn away, leaving the strap detached along the box stitched square area.Another area of the foam has a significant crease.The torn foam and fabric edges appear clean and uniform, not frayed or degraded.Surrounding foam and stitching remain intact and show no signs of progressive wear or weakness.The velcro and loop components are intact and functional.Evaluation of the returned sensor (serial number 5175t161) was tested with an in-house alarm and passed all functional testing despite the visual damage observed.Possible cause for the tear at the strap attachment appears to be consistent with force-related separation due to tensile overload or stress during use.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: 23352199
• Report Number: 2182318-2025-00092
• Device Sequence Number: 18411073
• Product Code: KMI
• UDI-Device Identifier: 10190676006202
• UDI-Public: 10190676006202
• 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): 09/23/2025

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: 8399
• Device Catalogue Number: 8399
• Device Lot Number: 5196T192
• 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: 09/23/2025
• Initial Report FDA Received Date: 10/21/2025
• 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