MAUDE Adverse Event Report: TIDI PRODUCTS LLC SITTER ON CUE PRO; MONITOR, BED PATIENT

Model Number	8645WL
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based solely on the information provided by the customer.Product was not returned, therefore, confirmation of customer's complaint and the root cause could not be determined.A review of the complaint database revealed 15 other events similar to the reported issue in the past two years.Product was not returned for 4 of the complaints.Of the products that were returned, 2 were found to have no power due to damage on the on/off switch, 1 was found to have a damaged j2(sensor receptacle) and 8 units were found to meet specification and pass all functional testing.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 if the alarm and/or sensor do not function properly, remove the alarm and sensor from service and replace them with a properly functioning alarm and/or sensor.Do not use the alarm or sensor if it does not activate each time weight is removed from the sensor, or if the chair belt sensor is unfastened.Ensure the nurse call cable is plugged into both the fall monitor and the wall port of the nurse call system or that the wireless adapter is paired properly before leaving the patient unattended.Verify that an alert is received at the nursing station.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.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.Manufacture reference file (b)(4).
Event or Problem Description
Customer reported 1 8645wl alarm not working properly.Patient fall.Posey alarm had been armed and tested, but it did not sound until the nurse was already in the room, and the patient had already been on the ground for about 30 seconds.The team confirmed that the patient had been entirely off the pad and it was not on hold.No patient injury.Sn: (b)(6).

• Brand Name: SITTER ON CUE PRO
• 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: 22746075
• Report Number: 2182318-2025-00077
• Device Sequence Number: 11893713
• Product Code: KMI
• UDI-Device Identifier: 00190676007639
• UDI-Public: 00190676007639
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 07/11/2025

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: 8645WL
• Device Catalogue Number: 8645WL
• 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: 07/11/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2024
• 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