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

Model Number	8283
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned for evaluation, therefore, this report is based solely on the information provided by the customer.The product lot number was not provided, therefore the device history review could not be performed.The sensor pad works as intended and continues to be put into use, however, the metal clip attached to the sensor pad is being removed to avoid further instances.A review of the complaint database revealed one other event against this issue.Product was not returned in this instance but customer noted that they are removing the clip to avoid any issues.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.Failure to follow these instructions could result in serious injury.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.Manufacturing reference file (b)(4).
Event or Problem Description
Customer reported complaint, caregiver reported that patients develop deep tissue injuries from use of bed pad on mattress.

• 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: 22287929
• Report Number: 2182318-2025-00060
• Device Sequence Number: 8467342
• Product Code: KMI
• UDI-Device Identifier: 10190676004376
• UDI-Public: 10190676004376
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/22/2025

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: 8283
• Device Catalogue Number: 8283
• 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: 05/22/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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