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)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based solely on the information provided by the customer.Due to product not being returned, reported issue cannot be determined with only the information available.A review of the complaint database revealed similar complaints of 8345 alarms either sounding when they shouldn't or not sounding when they should.Investigations into these complaints revealed that the most likely cause of the reported complaint is either damage to the sensor receptacle or damage to the rj-11 clip.Damage can cause the pins inside the sensor receptacle to become stuck down, either triggering no alarm or false alarm.It can also cause the sensor cable to not have a secure fit in the receptacle, which can allow movement to affect function.Likewise with damage to the sensor cable clip.Other causes, such as corrosion and moisture damage, are also a possibility.Being that the unit is already more than 3 years old since it was manufactured, it is unlikely that a manufacturing non-conformity contributed to the unit having no sound, and the likely cause of the reported issue is normal wear-and-tear.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The instructions for use state: 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.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.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.Medwatch report (b)(4) / manufacturer reference file (b)(4).
Event or Problem Description
Uf/importer report (b)(4).Complaint reported via the fda, sn (b)(6) item # 8345, discontinued, ordered on 5/17/22.Complaint event date was 5/17/24 emailed report on 7/26/24.It was reported a chair alarm did not go off as designed.Alarm noted to be in on position, but when tested, did not activate when seat belt undone, as it should.When unplugged from seat belt and turned on, alarm sound would work, but not when plugged in.Alarm switched out, and new alarm worked when engaged and plugged in and seat belt undone, leading us to suspect problem with jack port.Alarm pulled from service.
Event or Problem Description
Uf/importer report (b)(4).Complaint reported via the fda, sn (b)(6) item #8345, discontinued, ordered on (b)(6) 2022.Complaint event date was 5/17/24 emailed report on (b)(6) 2024.It was reported a chair alarm did not go off as designed.Alarm noted to be in on position, but when tested, did not activate when seat belt undone, as it should.When unplugged from seat belt and turned on, alarm sound would work, but not when plugged in.Alarm switched out, and new alarm worked when engaged and plugged in and seat belt undone, leading us to suspect problem with jack port.Alarm pulled from service.
Additional Manufacturer Narrative
H3 this report is based solely on the information provided by the customer.Due to product not being returned, reported issue cannot be determined with only the information available.A review of the complaint database revealed similar complaints of (b)(4) alarms either sounding when they shouldn't or not sounding when they should.Investigations into these complaints revealed that the most likely cause of the reported complaint is either damage to the sensor receptacle or damage to the rj-11 clip.Damage can cause the pins inside the sensor receptacle to become stuck down, either triggering no alarm or false alarm.It can also cause the sensor cable to not have a secure fit in the receptacle, which can allow movement to affect function.Likewise with damage to the sensor cable clip.Other causes, such as corrosion and moisture damage, are also a possibility.Being that the unit is already more than 3 years old since it was manufactured, it is unlikely that a manufacturing non-conformity contributed to the unit having no sound, and the likely cause of the reported issue is normal wear-and-tear.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The instructions for use state: 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.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.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.Medwatch report (b)(4) / 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: 20054132
• Report Number: 2182318-2024-00109
• Device Sequence Number: 12751453
• Product Code: PJO
• UDI-Device Identifier: 10190676002082
• UDI-Public: 10190676002082
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: 2123KF1795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2021
• 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: Male
• Patient Race: White