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

Model Number	8399
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 product is not available for return or evaluation.Therefore, this report is based solely on the information provided by the customer that resulted in a patient fall.Customer confirmed a liquid substance was embedded within the velcro attachment of the belt causing the alarm to not sound when patient self-released the belt.The instructions for use ifu cleaning instructions state: if the hook and loop straps become wet, alarm may not sound.Excess moisture may prevent sensor from activating, increasing risk of injury.If straps become wet, discontinue use until completely dry.If necessary, use a stiff brush to remove dust and lint from hook and loop.Additionally, the territory manager (b)(6) confirmed training was performed with staff on application of the head start belts.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).
Event or Problem Description
Customer reporting a complaint on product 8399.Customer states that food liquid became embedded in the velcro attachment of the headstart chair sensor belt, this caused a no alarm which led to a patient incident/fall.Patient self released the belt & alarm did not sound then patient had a fall, the type of injury is not specified.Product is not available for return according to report.

• 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: 20848924
• Report Number: 2182318-2024-00165
• Device Sequence Number: 3759874
• Product Code: KMI
• UDI-Device Identifier: 10190676006202
• UDI-Public: 10190676006202
• 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): 11/08/2024

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: 8399
• Device Catalogue Number: 8399
• Device Lot Number: UNKNOWN
• 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: 11/08/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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