MAUDE Adverse Event Report: TIDI PRODUCTS LLC ALARM SENSOR, CHAIR SENSOR; MONITOR, BED PATIENT

Model Number	8309WL
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
Customer reported, according to the rn, the patient sat on the chair alarm, heard the beep, and got up for a little so the nurse could adjust the chair pad, and sat back down.When the patient got up , the chair alarm did not alarm.Patient injury, patient sustained minor injury to right knee.Chair sensor not available, as this has been disposed of.
Additional Manufacturer Narrative
Product is not available for return, therefore, this report is based solely on the information provided by the customer.A tidi representative communication with the facility determined that the fall occurred when the alarm had been put on a 5 minute hold and the staff member left the room before the alarm light was green.Re-education was provided to staff members to know how to put alarm on 30 second or 5 minute hold and how to release the alarm from the hold.A device history record (dhr) of the affected lot number did not reveal any issues that could have contributed to the reported incident.No ncrs were identified.The product passed all verification testing and met manufacturing specifications prior to being released for distribution.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, and the instructions for use were reviewed and determined to provide adequate instructions and warning 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 warrant.Manufacturer reference file (b)(4).

• Brand Name: ALARM SENSOR, CHAIR SENSOR
• 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: 22850093
• Report Number: 2182318-2025-00081
• Device Sequence Number: 4419147
• Product Code: KMI
• UDI-Device Identifier: 00190676007653
• UDI-Public: 00190676007653
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/25/2025

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: 8309WL
• Device Catalogue Number: 8309WL
• Device Lot Number: 5120T385
• 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: 07/25/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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