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

Model Number 8399L

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

H3: this report is based solely on the information provided by the customer.A device history (dhr) review found no non-conformances or anomalies related to the lot number associated with this complaint, units passed testing prior to release for distribution.Historical review of the complaint database for the last two years revealed 4 other instances where the belt ripped at the seams.Two of the complaints were returned for evaluations, and investigations revealed user error as the foam materials of the returned sensor belt were being torn apart.The other two complaints product was not returned for evaluation.Sample and complaint recreation were performed by the engineering team.They were not able to replicate the customer experience of breaking the foam with only their hands.The only way to cut the foam (clean cut) is if the area was previously cut damaged, in this case a knife was used to cut the blue fabric and then the foam was able to tear apart.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 (b)(4).H3 other text : product not returned.

Event Description

Customer reporting a complaint on product # 8399l.(b)(6).Customer states they had a clean break of 8399l with a patient in a wheelchair.The break caused the patient to fall forward.The patient did not suffer any injuries.The belt broke just before the box stitch.

• Brand Name: DISPOSABLE CHAIR ALARM BELT LONG
• 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: 18852013
• MDR Text Key: 337850357
• Report Number: 2182318-2024-00014
• Device Sequence Number: 1
• Product Code: KMI
• UDI-Device Identifier: 10190676006288
• UDI-Public: 10190676006288
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8399L
• Device Catalogue Number: 8399L
• Device Lot Number: 3306T017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2023
• 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