MAUDE Adverse Event Report: INVACARE TAYLOR ST. 3G TORQUE 3; POWERED WHEELCHAIR

Model Number NA:3GTQ3-CG

Device Problem Device Slipped (1584)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

It is unknown what, if any malfunction of the device occurred.Invacare is awaiting the return of the device at which time an expanded evaluation will be performed.It was confirmed there was a functioning seat positioning strap installed on the chair at the time of the incident, but it was not being used.The owner¿s manual for this device provides safety and warning instruction¿s including: danger risk of death or serious injury, not wearing your seat positioning strap could result in death or serious injury.Always wear your seat positioning strap.Your seat positioning strap helps reduce the possibility of a fall from the wheelchair.Warning risk of injury, damage or death loss of traction or stability on inclines/grades or ramps may cause injury, damage or death.

Event Description

On 9/24/2020 the end users¿ physical therapist provided the following information: in (b)(6) 2020 the end user was going down a ramp and the chair skidded.The chair caught the edge of the ramp causing it to jerk and tip up on one side, to her knowledge the chair did not fully tip over.The end user was not wearing the seat positioning strap at the time of the incident and was thrown from the wheelchair.The end user sustained a leg fracture and required surgery.

Event Description

On (b)(6) 2020 the end users¿ physical therapist provided the following information: in (b)(6) of 2020 the end user was going down a ramp and the chair skidded.The chair caught the edge of the ramp causing it to jerk and tip up on one side, to her knowledge the chair did not fully tip over.The end user was not wearing the seat positioning strap at the time of the incident and was thrown from the wheelchair.The end user sustained a leg fracture and required surgery.

Manufacturer Narrative

The device received an expanded evaluation.Utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for the wheels slipping or moving on their own.There was no malfunction of the device observed during testing.Lt is unknown the conditions of the ramp that might have caused or contributed to the slipping of the wheels that led to the injury.

• Brand Name: 3G TORQUE 3
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44036
• MDR Report Key: 10643923
• MDR Text Key: 210370696
• Report Number: 1525712-2020-00023
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:3GTQ3-CG
• Device Catalogue Number: 3GTQ3-CG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR