MAUDE Adverse Event Report: TIDI PRODUCTS LLC SAFETY VEST; RESTRAINT, PROTECTIVE

Model Number 3060M

Device Problem Human-Device Interface Problem (2949)

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.Without the return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be confirmed.A review of the complaint database revealed one other complaint in the past 2 years where the strap was reported as being too long.The complaint was received from the same care facility as this complaint.In both cases product was not returned for evaluation.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 warns never alter or repair this product.Always inspect before each use: check for broken stitches or parts; torn, cut or frayed material; or locks, buckles, or hook-and-loop fasteners that do not hold securely.Do not use soiled or damaged products.Doing so may result in serious injury or death.Dispose of damaged products per facility policy for biohazardous material.Contraindications: do not use on a patient who is or becomes highly aggressive, combative, agitated, or suicidal.Warnings state 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.Without return of the device the reported issue could not be confirmed.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.Therefore, no further 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 warranted.Manufacturer reference file (b)(4).

Event Description

Customer is reporting a complaint on roll vest 3060m.Customer states that the strap material is too long for the roll vests.The length makes it easy for the patients to unclip the buckle and remove the restraint.

• Brand Name: SAFETY VEST
• Type of Device: RESTRAINT, PROTECTIVE
• 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: 18188077
• MDR Text Key: 328922389
• Report Number: 2182318-2023-00111
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676002600
• UDI-Public: 10190676002600
• 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: 10/24/2023

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: 3060M
• Device Catalogue Number: 3060M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/21/2023
• 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?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1