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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reporting a complaint on products 8645wl & 8309wl.Customer is reporting a fall incident involving a patient.Customer did not specify if patient was injured as a result.Customer states that the fall took place due to the alarm not sounding.The nurse that found the patient said that the unit and pad needed to be paired again.
Additional Manufacturer Narrative
H3 the report is based solely on the information provided by the customer.The serial number was not provided; therefore, the dhr for this alarm cannot be reviewed.Customer confirmed issue with the unit not sounding was likely due to the unit being turned off and when turned back on it was not re-paired prior to fall.After the fall, staff was able to re-pair the pad with the alarm and it worked as intended.The tm will be conducting a retraining with the entire team for application / pairing of the devices at the end of (b)(6) 2024.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, test fall monitor functionality every time before each use and when leaving the patient unattended.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.Moreover, the wireless alarm setup guide also states, turning off the alarm unpairs the wireless chair sensor pad.Never turn off the wireless nurse call adapter or it will unpair from the alarm.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).

• 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: 20750031
• Report Number: 2182318-2024-00155
• Device Sequence Number: 11859093
• 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): 10/24/2024

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: 10/24/2024
• Initial Report FDA Received Date: 11/21/2024
• 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