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	Laceration(s) (1946)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the product 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)(4), 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).
Event or Problem Description
Customer reporting a complaint on product 8309wl lot# 4304t148.Customer state that they recently had a patient incident on (b)(6) 2024.The patient was in their chair with our 8309wl paired to the alarm.The patient got up and fell.Alerted staff by yelling.The alarm did not sound when the patient stood up.A foley was pulled out and a laceration occured.Staff re-paired the sensor & alarm and it still didn't sound alarm.Staff tried a new sensor, the new sensor worked correctly paired/sounded.Customer has original pad still to return for evaluation.

• 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: 21223603
• Report Number: 2182318-2024-00182
• Device Sequence Number: 20978353
• Product Code: KMI
• UDI-Device Identifier: 00190676007653
• UDI-Public: 00190676007653
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/26/2024

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: 8309WL
• Device Catalogue Number: 8309WL
• Device Lot Number: 4304T148
• 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: 12/26/2024
• Initial Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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