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

Model Number	8345
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual findings of the unit revealed no physical damages on the exterior housing.Evaluation of the unit found that the unit had power with batteries installed in the compartment but did not sound when nothing was connected.Additionally, the unit had no power when in use with an ac adapter.Upon opening the unit, there were three faulty electronic components observed on the printed circuit board assembly (pcba) causing the unit for not working as intended.The speaker circuitry was found out to have u3 (audio amplifier) and q9 (transistor) faulty components while the power circuitry was found out to have a r2 (resistor) faulty component.After replacing all faulty components, the unit functioned properly when in use with a magnet and sensor pad.This could be caused by using the unit with a non-posey ac adapter which has a higher voltage output leaving the unit for not functioning as intended for use.Consequently, the customer was notified via email with instruction for use attached reminding them to only use posey ac adapters with our alarms to ensure proper alarm function and to prevent damage to the alarms.If the fail-safe is not working, it may not alert the caregiver if a sensor is disconnected or not working and could contribute to a patient incident.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.A device history record (dhr) of the affected serial number did not reveal any issues that could have contributed to the reported incident.No ncrs were identified.The unit passed all verification testing and met manufacturing specifications prior to being released for distribution.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.Manufacture file reference # (b)(4).
Event or Problem Description
Customer reported an alarm via email that the alarm does not make sound.No physical damage or mute mode observed.

• Brand Name: SITTER ELITE
• Common Device Name: FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 570 enterprise; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15457778
• Report Number: 2182318-2022-00109
• Device Sequence Number: 6864297
• Product Code: PJO
• UDI-Device Identifier: 10190676002082
• UDI-Public: 10190676002082
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/22/2022

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: 1925KF0825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2019
• 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