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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based solely on the customer¿s allegation that resulted in a patient fall.A review of the device history record could not be performed, since the product serial number was not provided.Product was not returned for evaluation, as the device was returned to hospital inventory.The unit worked as intended after the batteries were changed.The posey sitter on cue alarm is designed to maintain full function when there is a low battery alert until the batteries are completely depleted.The posey alarm will still sound and send a signal to the nurse call station as intended.The ifu warns the user to not allow batteries to deplete while in the alarm.Change batteries immediately when hearing the low battery chirp.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.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.Manufacturer reference file (b)(4).
Event or Problem Description
Customer had patient fall with our alarm.Alarm did not sound; batteries were changed and alarm worked as intended.Limited information as tm will be visiting customer to obtain further info.No sn available.

• 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: 21950445
• Report Number: 2182318-2025-00050
• Device Sequence Number: 8836262
• Product Code: KMI
• UDI-Device Identifier: 10190676007131
• UDI-Public: 10190676007131
• 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): 04/04/2025

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?: No
• Device Model Number: 8645
• Device Catalogue Number: 8645
• 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: 04/04/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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