MAUDE Adverse Event Report: SMITH & NEPHEW INC. TENENT (SMITH AND NEPHEW) T-MAX SHOULDER POSITIONER; T-MAX BEACH CHAIR

Model Number "A" 4269

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 04/06/2017

Event Type  Injury  

Event Description

The pt was transferred from the stretcher to the operating room table with t-max attachment.After adjusting to desired position, the stretcher was moved away to that the safety strap could be applied.At this time there was aloud snap and the metal clamps fastening the t-max to the operating room table broke.The t-max attachment fell back and broke away from the bed, with the pt's upper body landing on the floor.This equipment is usually set up by hospital assistants, but in this instance was prepared by two nurses who do not typically do so.When the nurses slid the t-max onto the amsco 3085 bed rails, the t-max arms entered the square rail clamps and stopped once the bottom flange of the arm met with the bolt attaching the rails with the amsco 3085 bed.The nurses believed that this was as far as the attachment would go, and that it was properly connected to the bed.In reviewing this event, it was determined that the nurses had not positioned the beach chair according to directions indicated on the chair itself, and there was an approx one inch gap between the t-max attachment and the bed.This gap was obscured by the mattress pad on the operating room bed.Due to the improperly assembled equipment, the only thing holding the t-max to the bed was the two rail clamps, which are not designed to support the weight of the attachment and pt.Proper placement of the chair would result in load bearing "beams" secured by the brackets.Because the chair was appropriately placed, the brackets inappropriately bore the load of the pt.

• Brand Name: TENENT (SMITH AND NEPHEW) T-MAX SHOULDER POSITIONER
• Type of Device: T-MAX BEACH CHAIR
• Manufacturer (Section D): SMITH & NEPHEW INC.; calgary, alberta ; CA
• MDR Report Key: 7159788
• MDR Text Key: 96372689
• Report Number: MW5074340
• Device Sequence Number: 0
• Product Code: FWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: "A" 4269
• Device Lot Number: 3170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1