MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX; WHEELCHAIR, POWERED

Model Number TDXSPREE

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

Rma has been issued for the return of this device.Device has been returned.Detailed evaluation in progress at the time of this investigation.Should additional information become available a supplemental record will be filed.

Event Description

The (b)(6) states the stability lock keeps getting locked up.The (b)(6) states the drive tire was spinning without making contact with the ground causing the chair to spin in a circle erratically.(b)(6) added (b)(4) 2015 that the end user's family has shown him where some type of holes were in the walls due to this issue.(b)(6) was contacted by csr/tech on (b)(4) 2015 to assist with troubleshooting.The (b)(6) is alleging the same as listed that the stability lock cylinder is sticking on the left side.(b)(6) states the school will not allow it back into the school because they say it is unsafe.

Manufacturer Narrative

Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the left stability lock cylinder locking up in the extended position.The absence of loctite on the left stability lock cylinder rod end threads allowed the end to back out of the pivot ball.This condition caused the release pin to not be sufficiently depressed enough to disengage the stability lock cylinder.The right stability lock cylinder did not contain the proper loctite.The right stability lock cylinder rod end did not back out of the pivot ball.The loctite that was present on the right stability lock cylinder rod end threads was from the locking collar mounting bolts.The right side stability locking system functioned properly.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

The tbm states the stability lock keeps getting locked up.The tbm states the drive tire was spinning without making contact with the ground causing the chair to spin in a circle erratically.Tbm added (b)(6) 2015 that the end user's family has shown him where some type of holes were in the walls due to this issue.Tbm was contacted by csr/tech on (b)(6) 2015 to assist with troubleshooting.The tbm is alleging the same as listed that the stability lock cylinder is sticking on the left side.Tbm states the school will not allow it back into the school because they say it is unsafe.

Manufacturer Narrative

Product received additional expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the left stability lock cylinder locking up in the extended position.A visual examination of the returned cylinder assemblies were performed under magnification (10x) and showed evidence that loctite was present, albeit only a minimal amount.This minimal amount of loctite allowed the locking cylinder rod end threads to back out of the pivot ball.This condition prevented the release pin from sufficiently depressing to disengage the stability lock cylinder, thus resulting in the cylinder being stuck at an extended length, which allowed the left swing arm to become stuck in a raised position.Although the right stability lock cylinder did not contain the proper amount of loctite, the rod end did not back out of the pivot ball.The right side stability locking system functioned properly.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

The tbm states the stability lock keeps getting locked up.The tbm states the drive tire was spinning without making contact with the ground causing the chair to spin in a circle erratically.Tbm added (b)(4) 2015 that the end user's family has shown him where some type of holes were in the walls due to this issue.Tbm was contacted by csr/tech on (b)(4) 2015 to assist with troubleshooting.The tbm is alleging the same as listed that the stability lock cylinder is sticking on the left side.Tbm states the school will not allow it back into the school because they say it is unsafe.

• Brand Name: TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX
• 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: 5264655
• MDR Text Key: 32859316
• Report Number: 1525712-2015-05475
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2016

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 Operator: Lay User/Patient
• Device Model Number: TDXSPREE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/14/2016; 02/08/2016
• 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: Reuse
• Patient Sequence Number: 1