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

Model Number	8309EL
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported at least three incidents- two of which resulted in injury falls where the patient was found out of their chair.Not alarming and continued blinking green indicating the unit was active.The customer had personally investigated all three occurrences and confirmed the chair pads were not detecting weight when applied or removed alarms were switched with new pads and worked.Only two pads are available for return.Lot#'s 5205t188 and 6098t235.
Additional Manufacturer Narrative
Product was received and evaluated.Visual findings did not observe any damage to sensor that would explain the reported malfunction.During evaluation, both ends of the wired connections on the sensor wire were inspected and tested for loose connections and incorrect wiring.No issues were identified.The sensor film was cut and the foam removed to view the soldered connections and brass crips, there were no signs of any issues, crips looked good and wires were soldered firmly in place.The reported malfunction could not be duplicated during evaluation.The unit consistently recognized the sensor, and all activation tests operated as intended.Despite the evaluation results, the tidi representative is continuing to work with the facility to address any identified issues.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).

• 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: 50550670
• Report Number: 2182318-2026-00089
• Device Sequence Number: 18790904
• Product Code: KMI
• UDI-Device Identifier: 10190676004369
• UDI-Public: 10190676004369
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/03/2026

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?: No
• Device Model Number: 8309EL
• Device Catalogue Number: 8309EL
• Device Lot Number: 6098T235
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• 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: 08/03/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2026
• 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