MAUDE Adverse Event Report: TIDI Products LLC SITTER ON CUE PRO; Monitor, Bed Patient

Model Number	8645WL
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Supplemental medwatch being sent for additional information.Original complaint stated: sitter on cue unit not working properly.Intermittently powers on.No patients were involved or injuries reported.Evaluation completed.See section h11.Device manufacturers only.
Additional Manufacturer Narrative
Product was returned and evaluated.The reported issue of the unit having intermittent power was not confirmed.Functional testing was performed using both aa batteries and the ac power adapter.The unit remained powered on throughout the evaluation period, and the reported intermittent power condition could not be reproduced.Following testing, the unit was disassembled and the printed circuit board was visually inspected.No damaged components, discoloration, or other abnormalities were observed.Based on the evaluation conducted, no evidence was identified to confirm the reported intermittent power issue.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 ; +1(920)751-4300
• MDR Report Key: 50847504
• Report Number: 2182318-2026-00103
• Device Sequence Number: 10025798
• Product Code: KMI
• UDI-Device Identifier: 00190676007639
• UDI-Public: 00190676007639
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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
• Device Lot Number: 2246KN0613
• Was Device Available for Evaluation?: No
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown