MAUDE Adverse Event Report: TIDI PRODUCTS DISPOSABLE CHAIR ALARM BELT; FALL PREVENTION ALARM/SENSOR ATTACHED ONLY

Model Number	8399
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer is reporting a complaint about 8399.The customer states that plenty of their 8399 will not alarm when first layer is pulled.They have tried to remove the 8399 and plug back in to verify issue.It did alarm when they removed the belt plug from the alarm.After plugging it back in and the green light came on they tried again the 8399 would not alarm.The date the issue was discovered is unknown and no patient incident or injury was reported.
Additional Manufacturer Narrative
Device evaluated by mfr: evaluation of the returned product found when the sensor belt was tested with a known working 8645 unit, it did not trigger the unit when the outer hook and loop were disengaged due to two conductive striped fabric materials overlapped at the end when they were sewn to attach to the foam material.The issue has been addressed internally via corrective action.A review of the complaint database did not reveal any similar events against this device in the past 2 years.Therefore, it appears that this complaint was an isolated event.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Ifu instructs to check that alarm is on and that alarm belt/alarm system is working properly each time before leaving patient unattended.Pull first yellow strap to activate alarm then re-connect for monitoring.Stop use at once if alarm fails to sound.All complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.No corrective or preventative actions are necessary at this time.Manufacturer reference file (b)(4).

• Brand Name: DISPOSABLE CHAIR ALARM BELT
• Common Device Name: FALL PREVENTION ALARM/SENSOR ATTACHED ONLY
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 16533087
• Report Number: 2182318-2023-00015
• Device Sequence Number: 7243658
• Product Code: PJP
• UDI-Device Identifier: 10190676006202
• UDI-Public: 10190676006202
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/13/2023

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: 8399
• Device Catalogue Number: 8399
• Device Lot Number: 2031T014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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