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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Tm reported complaint via email.Issue occurred with sn (b)(6) (expired alarm), but resulted with a patient incident/injury.Per the tm: sitter elite alarm with the 8399l-headstart chair belt.Alarm did not go off when patient self-released the headstart belt.Patient fell at 3 pm today and is on their way to have ct scan to identify any injuries.
Additional Manufacturer Narrative
H3: 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 5 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.Manufacturer reference file (b)(4).Product not returned.
Event or Problem Description
Supplemental medwatch being sent for additional information.
Additional Manufacturer Narrative
The original unit was returned for evaluation.Visual findings observed the alarm unit received with a sensor belt.Indentations noted on the exterior housing.Both dust covers underneath the battery slots are broken, and the broken pieces fell inside the unit causing a rattling sound when the unit was shaken.Brown residue was observed outside the battery compartment.Creases were observed on the foam strap of the sensor belt as a sign of normal wear and tear.Evaluation found the returned alarm unit sounded when the returned sensor belt hook and loop were detached, and it did not sound when the hook and loop were attached as intended.The alarm passed all functional testing.The returned sensor belt was also evaluated with an in-house alarm unit, and it functioned as intended.The instructions for use (ifu) were reviewed and were 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.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: 18951378
• Report Number: 2182318-2024-00031
• Device Sequence Number: 7084563
• Product Code: PJO
• UDI-Device Identifier: 10190676002082
• UDI-Public: 10190676002082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2018
• 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