MAUDE Adverse Event Report: TIDI PRODUCTS LLC ALARM SENSOR, 30-DAY BED SENSOR PAD; MONITOR, BED PATIENT

Model Number	8283
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
Customer states that the product 8645 failed to alarm while in use with an 8283 pad.It is stated that the patient stood up, and the alarm stayed green.This resulted in a patient fall.The customer reported that there were no injuries resulting from the fall.
Additional Manufacturer Narrative
The evaluation indicates that the alarm has scratches on the exterior housing and was received with batteries inside.The sensor pad was not returned flat as it was folded and stuffed inside the fedex box with the alarm.There are creases observed throughout the pad as a result of folding and normal wear and tear.The first use and expiration dates were not filled in by the customer.The alarm and sensor pad are functional and will perform as intended.Both alarm and sensor passed all functional testing.The possible root cause is that the user may have been used a memory foam, overlay, or low air-loss mattress.The sensor has a warning printed on the pad stating not to use the sensor with these types of mattresses as a foam pad on top of the mattress may diffuse patient's weight and prevent sensor pad from activating.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, testing of the device in question shows no evidence that a manufacturing nonconforming contributed to the reported complaint.Therefore, no corrective or preventive actions will be initiated at this time.Per tidi procedures, complaints for this device will continue to be trended and reviewed on a monthly basis.Manufacture reference file number (b)(4).

• Brand Name: ALARM SENSOR, 30-DAY BED SENSOR PAD
• 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: 17873995
• Report Number: 2182318-2023-00102
• Device Sequence Number: 12577348
• Product Code: KMI
• UDI-Device Identifier: 10190676004376
• UDI-Public: 10190676004376
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2023

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: 8283
• Device Catalogue Number: 8283
• Device Lot Number: 2355T069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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