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

Model Number	8345
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer contacted via phone stating that the alarm will continue to alarm intermittently.Issue also occurs when the alarm is turned off.Initial troubleshoot via phone corrected issue, but continued on within the hour since.
Additional Manufacturer Narrative
The device was returned and evaluated by posey products; at which time, it was found to be functioning according to manufacturing specifications.The visual findings revealed signs of normal wear and tear on the exterior housing from repeated use as the device has scratches and indentations on the exterior housing and broken dust covers underneath the battery slots.Additionally, the moisture indicator label attached in the compartment has turned red color from white color indicating that the unit was exposed to moisture.Even if cosmetic damage is noted, the evidence supports that a device malfunction did not occur.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.Try a new sensor if the intermittent alarm cannot be fixed.Make sure mattress continues to make contact with the sensor and will activate the alarm when pressure is removed, even if the head or foot of the bed is articulated.Apply pressure to sensor in several areas to check that alarm activates.At this time, testing of the device in question shows 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).

• 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: 18154606
• Report Number: 2182318-2023-00110
• Device Sequence Number: 15100083
• Product Code: PJO
• UDI-Device Identifier: 10190676002082
• UDI-Public: 10190676002082
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/19/2023

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: 2050KF0275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• 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