MAUDE Adverse Event Report: TIDI Products LLC CHAIR SENSOR PAD EXT.CABL; Monitor, Bed Patient

Model Number	8309EL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported patient fall during use.Item 8309el lot 961967, request for both alarm and sensor pad to be returned.
Additional Manufacturer Narrative
The report is based solely on the information provided by the customer.A tidi representative confirmed that the patient did not sustain any injuries and evaluated the alarm after the event and confirmed that the alarm functioned as intended.The sensor pad had been discarded and will not be returned for evaluation, therefore root cause could not be determined.A review of the device history record could not be performed, because the lot number provided is an incorrect number.A review of the complaint database revealed similar complaints that resulted in a patient fall for alarms either sounding when they shouldn¿t or not sounding when they should.Investigations into these complaints revealed that the most likely cause of the reported complaint is either damage to the sensor receptacle or damage to the rj-11 clip.Damage can cause the pins inside the sensor receptacle to become stuck down, either triggering no alarm or false alarm.It can also cause the sensor cable to not have a secure fit in the receptacle, which can allow movement to affect function.Likewise with damage to the sensor cable clip.Other causes, such as corrosion and moisture damage, are also a possibility.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.Never jerk or pull on the cord to remove the sensor cord plug.Doing so will damage cord wires of fall monitor.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: CHAIR SENSOR PAD EXT.CABL
• 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: 50788820
• Report Number: 2182318-2026-00099
• Device Sequence Number: 13394135
• Product Code: KMI
• UDI-Device Identifier: 10190676004369
• UDI-Public: 10190676004369
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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?: Yes
• Device Model Number: 8309EL
• Device Catalogue Number: 8309EL
• Device Lot Number: 961967
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown