MAUDE Adverse Event Report: TIDI PRODUCTS LLC DISPOSABLE CHAIR ALARM BELT; MONITOR, BED PATIENT

Model Number 8399SL

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Customer reporting a complaint on product # 8399sl.Customer states that they had an additional seatbelt(8399) break.No injury or fall to the patient.The customer further states that the belt was applied correctly, no snagging or pull by wheelchair, and the belt broke in the same exact spot.

Manufacturer Narrative

H3 product is scheduled to be returned but has not been received in by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.Re-training was performed by (b)(6), a tidi clinical training specialist with encompass rehab hospital.It was noted that the facility only uses the head start chair belt in the wheelchairs, so they started primarily utilizing the 8399sl with the shorter grey cord that connects to the alarm hanging on the wheelchair.The education team notified that the application was an issue here as well with staff going around the back of the wheelchair instead of down the sides and even tying the straps instead of using the d rings.It was discussed the differences between the four sensor belts options, and it was concluded that the 8399lsl would be a better fit as it gives an extra 12inches of room around the patient and has the shorter grey cord for the wheelchair.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 ensure all parts of the system are operational before leaving the patient unattended.Failure to follow the instructions could result in serious injury.Before leaving the patient unattended, explain the purpose for the belt.Make sure the patient understands the need to call for assistance before exiting the chair and how to self-release.Additionally, the precautions section indicates that this product is a non-invasive way to monitor patient movement.This device does not prevent falls and is not a substitute for good nursing and regular visual monitoring.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 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).H3 other text : product not returned.

• Brand Name: DISPOSABLE CHAIR ALARM BELT
• Type of Device: MONITOR, BED PATIENT
• 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: 18980993
• MDR Text Key: 339331143
• Report Number: 2182318-2024-00037
• Device Sequence Number: 1
• Product Code: KMI
• UDI-Device Identifier: 10190676007933
• UDI-Public: 10190676007933
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8399SL
• Device Catalogue Number: 8399SL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1