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
Event or Problem Description
On (b)(6) 2025, bd1 customer reporting a complaint on product#: (s) 8645wl qty (b)(4), 8282wl we do not have lot#'s.(b)(6).Alarm #1 did not alarm when patient got up.Unknown if sensor was paired correctly.Patient fall.New alarm swapped and 2nd alarm failed to sound too which is alarm #2.These were both in rm (b)(4).No injury from 2nd or 1st fall.Product: 8282wl kept triggering the nurse call system falsely.Could not be corrected until a different 8282wl was tested.3rd alarm gave audible warning that maint was req'd.It would not alarm when patient got out of chair.No falls.Triggered chair exit alarm while patient was lying in bed.
Additional Manufacturer Narrative
H3: the device was returned and evaluated by tidi products; at which time it was found to be functioning according to manufacturing specifications.Even if cosmetic damage is noted, the evidence supports that a device malfunction did not occur.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.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.All complaints are trended and reviewed by management on a monthly basis.As a part of the 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).

• 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: 21256613
• Report Number: 2182318-2025-00003
• Device Sequence Number: 9060101
• Product Code: KMI
• UDI-Device Identifier: 00190676007639
• UDI-Public: 00190676007639
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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: 8645WL
• Device Catalogue Number: 8645WL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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