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

Model Number	8399
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Abrasion (1689); Skin Tears (2516)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has been received but evaluation of the device was not completed at the time of this report.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 2025-00779.
Event or Problem Description
Customer reported complaint via email; resulted in patient incident and injury.Per the customer: the patient leaned over, putting some weight on the belt.The belt gave way and the patient fell.The belt alarmed, and on inspection the blue velcro strap was not connected to the belt.Injury description: skin tear to elbow, abrasion to head.
Event or Problem Description
Supplemental medwatch being sent for additional information.
Additional Manufacturer Narrative
Product was returned and visual findings observed the belt was torn in half.Evaluation found the belt tear did not occur at the location where the blue velcro strap connects, instead the blue velcro strap connected properly and functioned as intended when paired with the qa fall monitor.The belt tear was in a separate area of the belt and not related to the strap connection or alarm activation.The belt alarm system appears to have functioned as designed.Historical review of the complaint database found similar instance where the belt ripped at the seams.Investigation into these complaints revealed possible user error as the foam and cable materials of the returned sensor belt appeared to be cut with a sharp object or excessive force.Additionally, the belt could have been subjected to weight-bearing use beyond its intended design.Product guidelines state; the belt is not intended to support the full weight of a patient.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.The evaluation results and a current copy of the ifu were shared with the initial reporter.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: DISPOSABLE 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: 22986520
• Report Number: 2182318-2025-00082
• Device Sequence Number: 15840178
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8399
• Device Catalogue Number: 8399
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2025
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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