MAUDE Adverse Event Report: TIDI PRODUCTS LLC ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY; 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	Malfunction
Event or Problem Description
Patient was sitting in bedside recliner and slid out of chair.The posey alarm did not go off and did not notify nurse call.The posey alarm was on, and sensor was plugged into alarm, nurse call was plugged in.When nurse placed patient in chair the alarm did say chair sensor activated.Following the incident the nurse set up the pad (same one with patient) and tested by pushing on the pad.They made a video recording to go along with this complaint.In the video it can be seen that after the sensor is activated and the nurse lifts pressure off the pad to trigger alarm, the alarm status light flashes and voice que says sensor attached, but alarm does not go off.In the video it can be seen that there is a low battery light flash indicating that the alarm had low battery.The customer was using procell batteries and when i turned the alarm on, the low battery indicator light flashed and the associate on site did hear low battery voice from speaker.The hospital uses ac power typically, but it was verified in video and from nurse that the ac power adapter was not plugged into alarm uring the incident which indicates that the low battery power may have been the cause of why the alarm did not function properly.According to staff involved, the nurse call cord was connected, but also did not trigger the nurse call.No patient incident or injury was reported.
Additional Manufacturer Narrative
H3 the device was returned and evaluated by tidi products; at which time it was found to be functioning according to manufacturing specifications.Even if cosmetic damage is noted, the evidence supports that a device malfunction did not occur.The complaint rate for this product family is (b)(6), which represents a very low rate of product defects.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.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: ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY
• 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: 21277636
• Report Number: 2182318-2025-00014
• Device Sequence Number: 9355286
• Product Code: KMI
• UDI-Device Identifier: 10190676004369
• UDI-Public: 10190676004369
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/07/2025

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: 4309T229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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