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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated by posey products; at which time, it was found to be functioning according to manufacturing specifications as the device sounded properly when in use with a sensor pad and passed all functional testing.The sensor pad was not returned flat as it was stuff inside a bio-hazard bag with a bubble wrap on the outside.The unit that was in use with the sensor pad was also placed inside the bio-hazard bag.Note attached on the bubble wrap stating the products have been cleaned and disinfected.The sensor pad has creases on throughout as a result of folding.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 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).
Event or Problem Description
Sitter on cue alarm with a serial number (b)(4) and 8309el sensor were reported with a patient fall.The date the issue was discovered is unknown and no incident or serious injury was reported.

• 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: 16379726
• Report Number: 2182318-2023-00016
• Device Sequence Number: 17616971
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2023

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: 8309EL
• Device Catalogue Number: 8309EL
• Device Lot Number: 2328T141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2022
• 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