MAUDE Adverse Event Report: TIDI PRODUCTS LLC ALARM SENSOR, 30-DAY BED SENSOR PAD; MONITOR, BED PATIENT

Model Number	8283
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is reported solely based on the medwatch information provided by the fda.Multiple attempts were made to obtain the product for evaluation and to gather additional details regarding the event and the nature of the injury; however, no response has been received to date.An investigation of similar complaints revealed several potential causes, including damages to either the alarm sensor receptacle or the sensor rj-11 clip.Damage to the sensor receptacle can cause the pins inside to become stuck down, either triggering no alarm or false alarm.It can also cause the sensor cable to not have a secure fit with the receptacle, allowing for movement to affect the function.Likewise with damage to the sensor cable clip.Other causes, such as corrosion and moisture damage, are also a possibility.A device history record (dhr) of the affected lot number did not reveal any issues that could have contributed to the reported incident.No ncrs were identified.The sensor passed all verification testing and met manufacturing specifications prior to being released for distribution instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Ensure all parts of the system are operational before leaving patient unattended.The ifu application instructions states; place bottom sheet over sensor pad.If needed, use an incontinence pad to protect sensor pad from urine or other liquids.Sensor pad may fail if liquid enters at neck of sensor pad.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.Therefore, no corrective or preventative actions are necessary.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
Fda complaint received report (b)(4).Per customer report, the bed alarm was placed under the patient.Bed alarm would not arm in posey monitor.

• Brand Name: ALARM SENSOR, 30-DAY BED SENSOR PAD
• 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: 24443890
• Report Number: 2182318-2026-00014
• Device Sequence Number: 10364542
• Product Code: KMI
• UDI-Device Identifier: 10190676004376
• UDI-Public: 10190676004376
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/26/2026

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: 8283
• Device Catalogue Number: 8283
• Device Lot Number: 5275T308
• 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: 01/26/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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