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

Model Number	8345
Medical Device Problem Code	Low Audible Alarm (1016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported complaint via phone call.Patient fall occurred with the alarm, volume was quiet upon sounding.
Additional Manufacturer Narrative
The customer was asked about the details of the fall incident via due diligence emails, but they were unable to provide information about the extent of the event whether the patient sustained an injury from the fall or not.Hence, this event is reported solely on the information provided by the customer.An investigation of similar complaints revealed several potential causes, including damage to either the alarm sensor receptacle or the sensor rj-11 clip.Damage to the sensor receptacle can cause the pins inside to become stuck down, either triggering no alarm or false alarm.It can also cause the sensor cable to not have a secure fit with the receptacle, allowing for movement to affect the function.Likewise with damage to the sensor cable clip.Other causes, such as corrosion and moisture damage, are also a possibility.With the information given and an alarm not being returned for evaluation, the root cause could not be determined.Being that the unit is already more than eight years old since it was manufactured, it is unlikely that a manufacturing non-conformity contributed to the unit having low volume, and the likely cause is one of the previous identified causes such as wear-and-tear, severe shock, moisture exposure, and other effects of repeated use and age.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).H3 other text : product not returned.

• 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: 18052166
• Report Number: 2182318-2023-00103
• Device Sequence Number: 6060314
• Product Code: PJO
• UDI-Device Identifier: 10190676002082
• UDI-Public: 10190676002082
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/06/2023

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: 8345
• Device Catalogue Number: 8345
• Device Lot Number: 1452KF1667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2014
• 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