MAUDE Adverse Event Report: INVACARE TAYLOR STREET POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED

Model Number 3GAR-CG

Device Problems Unintended Ejection (1234); Mechanics Altered (2984)

Patient Problem Injury (2348)

Event Date 09/17/2016

Event Type  malfunction  

Manufacturer Narrative

The product has been evaluated by invacare (b)(6).Tech service inspection and diagnosis found the motor and brake are working normal, upon inspecting the gearbox tech services found a tooth on the main gear broken off /missing.To their observation this may have caused the gearbox and motor to lock up and make the chair veer.Should additional information be obtained a follow up report will be issued.

Event Description

It was reported that the end user was driving her 3gar-cg power chair on the sidewalk when the chair suddenly veered to the right falling off the sidewalk.The end user was allegedly ejected into the street and almost hit by a car.After the incident the user allegedly pushed the unit over a distance of 200 meters (approximately 674 feet) to reach her residence.User sustained unknown back and arm injury along with posttraumatic stress.Medical intervention sought.

• Brand Name: POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6041524
• MDR Text Key: 57925508
• Report Number: 1525712-2016-02731
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3GAR-CG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1