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	Skin Tears (2516)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 this report is based solely on the information provided by the customer.Customer confirmed they will not be returning product since there was no product failure.Customer attempted to recreate issue but could not repeat.The product was reset and worked as intended.A device history (dhr) review found no non-conformances or anomalies related to the lot number associated with this complaint, units passed testing prior to release for distribution.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.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 velcro was no fastened and was laying to the sides of the chair.The alarm showed green and looked activated but no sound.It did not alarm when the patient removed velcro tab.The patient suffered a cut on their hand.Alarm was reset and seemed to work then.

• 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: 19082349
• Report Number: 2182318-2024-00046
• Device Sequence Number: 18069086
• Product Code: KMI
• UDI-Device Identifier: 10190676006202
• UDI-Public: 10190676006202
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/12/2024

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: 3291T030
• 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: 03/12/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• 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