MAUDE Adverse Event Report: TIDI PRODUCTS LLC KEEPSAFE DELUXE; FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED

Model Number	8374
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tm responded to the due diligence email stating that she asked the customer for more information about the event, but the customer elected not to share the extent of the patient injury.The customer identified that it was a user error and not equipment failure.The nurse did not have the right sensor plugged in to the 8374 device unit.They used two sensor pads (pn 8317 and 8309el) with the keepsafe deluxe on all fall risk patients.Each time they move the patient they have to unplug the chair and plug in the bed, etc.They are moving to the sitter on cue as a result (already placed their order) so both sensors can be plugged in together.Tidi will deploy clinical specialists to retrain the facility nurses in late january or early february 2024.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 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
Customer is reporting complaint on product # 8374.Customer states there was a sentianl event involving the posey alarm.No other given info was given regarding the event.

• Brand Name: KEEPSAFE DELUXE
• Common Device Name: FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED
• 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: 18409151
• Report Number: 2182318-2023-00122
• Device Sequence Number: 8767412
• Product Code: PJO
• UDI-Device Identifier: 10190676002143
• UDI-Public: 10190676002143
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/04/2023

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: 8374
• Device Catalogue Number: 8374
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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