MAUDE Adverse Event Report: TIDI PRODUCTS, LLC SITTER ELITE; FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED

Model Number	8345
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 bd1 the customer contacted us via phone call.Customer states that the alarm will not trigger nurse call system at the nurse station.Customer said they tired a new unit with where this alarm was and it worked.No apparent damage to the unit on the nc port or battery compartment.Sn (b)(4).
Additional Manufacturer Narrative
Visual findings observed the nurse call receptacle pin 3 inside was bent down.The warning label is peeling off from top edges.Site stickers attached at the lower end of the unit.Evaluation found the unit that it did not send a signal to activate the indicator light at the nurse call test fixture due to a bent pin 3 inside the nurse call receptacle.In addition, due to the bent pin 3, the mode button did not go into voice only and mute modes when the nurse call cable was plugged into the nurse call receptacle.The unit passed all other functional testing.If the device should fail to send a signal to the nurse call station, it may not alert the caregiver of a patient exit.Being that the unit is already more than two years old since it was manufactured, it is unlikely that a manufacturing non-conformity contributed to the bent pins inside the nurse call receptacle, and the likely cause of the event is normal wear and tear.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.The ifu states, to reduce the risk of serious injury or death, test the alarm and sensor for proper operation prior to putting in service with a patient, and each time before leaving the patient unattended.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, sensor or magnet if it does not activate each time weight is removed from the sensor, the chair belt sensor is unfastened, or magnet is removed from face plate.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this 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: SITTER ELITE
• 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: 15470317
• Report Number: 2182318-2022-00112
• Device Sequence Number: 4468634
• Product Code: PJO
• UDI-Device Identifier: 10190676002082
• UDI-Public: 10190676002082
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 8345
• Device Catalogue Number: 8345
• Device Lot Number: 2012KF0718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2020
• 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