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

Model Number	8645
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
Product is scheduled to be returned but has not been received by the manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.The 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 that to reduce the risk of serious injury or death, test the alarm and sensor for proper operation prior to putting in service with a patient, and each time before leaving the patient unattended.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 the sensor belt is unfastened.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 reported complaint that alarm did not sound, resulting in a patient fall.Sensor pad will also be returned with the alarm (8283).No patient incident or injury was reported.
Additional Manufacturer Narrative
Product was returned and evaluated.Visual findings observed the alarm unit and part 8283 sensor being returned.No damage observed to the alarm unit.Unit was received with aa batteries inside.The returned 8645 alarm and 8283 sensor operated as intended using both sensor ports.Sensor correctly triggered the alarm to begin monitoring when weight was applied in multiple different locations.Manipulation of the cord and connectors did not cut out the signal.Alarm correctly alarmed if weight was removed, and additionally correctly emitted the failsafe alarm when the sensor was unplugged while monitoring.The sensor was also tested with a secondary 8645 with no issues noted.See related reference file: (b)(4) / 2182318-2025-00064 for sensor results.The 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 that to reduce the risk of serious injury or death, test the alarm and sensor for proper operation prior to putting in service with a patient, and each time before leaving the patient unattended.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 the sensor belt is unfastened.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
Supplemental medwatch being sent for additional information.

• Brand Name: SITTER ON CUE
• 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: 22341811
• Report Number: 2182318-2025-00063
• Device Sequence Number: 21097420
• Product Code: KMI
• UDI-Device Identifier: 10190676007131
• UDI-Public: 10190676007131
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8645
• Device Catalogue Number: 8645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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