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

Model Number	V8309EL
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was returned and evaluated.Visual findings did not observe any damage.Evaluation found the returned chair sensor was evaluated using a qa-verified alarm to assess functionality across multiple sensor ports.Initial testing confirmed that the unit is capable of recognizing and activating a functional sensor.However, when the returned sensor was connected to sensor port 1, the unit did not consistently recognize the sensor.On occasions when recognition occurred, the unit displayed a blinking red indicator accompanied by an audible clicking sound.This behavior was intermittent and varied between connection attempts.Testing was repeated using sensor port 2 on the same qa-verified alarm, and similar intermittent behavior was observed.While the sensor successfully registered and activated on two occasions, overall performance remained inconsistent across both ports.Root cause was not determined and the sensor is being sent to engineering for further investigation.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, 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).
Event or Problem Description
Customer reported a patient fell.The chair sensor did not activate as intended.Lot 5240t192.
Additional Manufacturer Narrative
Engineering investigation did not find any issues with the chair sensor.Sme tested the sensor using both sensor ports on multiple fall monitors to confirm proper functioning of the sensor.The sensor's cord and plug was also manipulated to try to interrupt the signal with no interruption occurring.In all instances, the fall monitors immediately identified that a sensor was plugged into the proper port and placing weight on the sensor activated it as expected.When weight was removed, the alarm began alerting as anticipated.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.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).
Event or Problem Description
Supplemental medwatch being sent for additional information.

• Brand Name: NOVAPLUS SENSOR, CHAIR,
• 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: 23838790
• Report Number: 2182318-2025-00109
• Device Sequence Number: 9543948
• Product Code: KMI
• UDI-Device Identifier: 10190676006301
• UDI-Public: 10190676006301
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: V8309EL
• Device Catalogue Number: V8309EL
• Device Lot Number: 5240T192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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