MAUDE Adverse Event Report: TIDI PRODUCTS ROLL JACKET; RESTRAINT, PROTECTIVE

Model Number 3320M

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Manufacturer Narrative

This report is based solely on the information provided by the customer.Multiple attempts were made to collect information to confirm the part number and circumstances surrounding the adverse event.Due to product not being returned or the device part and lot number not being provided, the cause of the reported issue cannot be determined with only the information available.We have contacted our french distributor (b)(4) to gather investigative details.The distributor (b)(4) was unaware of the adverse event.(b)(4) contacted the medical facility where the incident occurred to gather additional details.The healthcare facility reported the patient was housed in a closed unit, the alzheimer life unit.The patient was established with a pyjadrap each evening, which the patient managed to remove multiple times.The posey roll jacket was applied as an emergency restraint due to behavioral problems with the patient following two repeated falls.The 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 to use side rail covers and gap protectors to help prevent the patient¿s body from going under, around, through or between the side rails.A failure to do so may result in serious injury or death if a patient becomes suspended or entrapped.A restraint applied incorrectly or worn backwards may result in serious injury or death from suffocation, chest compression or patient escape.Make sure straps cannot slide, loosen, or tighten if the patient pulls on them, or if the bed or chair seat position is adjusted.The patient may suffocate if the straps tighten.If the straps loosen, serious injury or death may occur from: patient escape; or from chest compression or suffocation if the patient becomes suspended in the restraint.Contraindications warns do not use on a patient who is or becomes highly aggressive, combative, agitated, or suicidal.A review of historical complaints internal and external demonstrate an acceptable safety profile, there have been no deaths or serious injuries reported.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.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 warrant.Manufacturer reference file (b)(4).

Event Description

Customer reported patient was using our product, and passed away from probable suffocation on thoracic compression in the context of restraint for a support vest.

• Brand Name: ROLL JACKET
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 9207514300
• MDR Report Key: 13810771
• MDR Text Key: 287425017
• Report Number: 2020362-2022-00015
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963442
• 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: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 3320M
• Device Catalogue Number: 3320M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/18/2022
• 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
• Patient Outcome(s): Death
• Patient Sex: Female