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

Model Number	8345
Medical Device Problem Codes	No Audible Alarm (1019); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Alarm does not properly sound even with active power.Magnet cord was tested and confirmed the issue.
Additional Manufacturer Narrative
The device was received in with damages to the dust covers in the battery slot, and the broken piece fell inside causing a rattling sound when the unit was shaken.Small indentation, sticky residue, and site sticker observed on the exterior housing.Functional testing found the alarm was not sounding when in use with the pull magnet.Testing of the impedance across the reed switch showed that the switch was faulty.This loss of functionality would result in the alarm failure to alert the caregiver of a patient exit and could contribute to a patient incident.Based on the age of the device, it is likely expected normal wear and tear that contributed to the faulty reed switch.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 number: (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: 18522188
• Report Number: 2182318-2023-00127
• Device Sequence Number: 3567663
• Product Code: PJO
• UDI-Device Identifier: 10190676002082
• UDI-Public: 10190676002082
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/18/2023

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: 8345
• Device Catalogue Number: 8345
• Device Lot Number: 2014KF1405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2020
• 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