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

Model Number TDXSP-CG

Device Problems Bent (1059); Leak/Splash (1354); Mechanical Problem (1384); Naturally Worn (2988)

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

Event Type  malfunction  

Event Description

Dealer stated that the cord for the right motor on a tdxsp-cg power chair has been shoved up into the motor cap breaking the seal on the motor causing it to leak grease.Dealer also stated that the end user backed into something, caused the left motor brake to bend and it is now leaking grease as well.The tires are worn out and the front rigging was covered in a sticky substance and needed to be swapped out as well.He states the end user wanted a foot board instead of individual foot plates.

• 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: 4625456
• MDR Text Key: 18918640
• Report Number: 1525712-2015-01944
• 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
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TDXSP-CG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2015
• 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
• Patient Outcome(s): Other