MAUDE Adverse Event Report: INVACARE TAYLOR STREET FDX BASE EUROPE W/12 IN REAR WHEELS; WHEELCHAIR, POWERED

Model Number FDX-MCG

Device Problems Bent (1059); Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.

Event Description

Dealer stating bolt on seating system came loose and made the seat come down crooked causing complications for the other components.When dealer tightened this bolt, he saw that the actuator was bent and the footrest was having problems.Actuator was replaced.Dealer may send back new actuator.(dealer thought just the actuator was the issue), but this has caused parts to bend and dealer afraid actuator will break again.

• Brand Name: FDX BASE EUROPE W/12 IN REAR WHEELS
• 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: 5675436
• MDR Text Key: 45790152
• Report Number: 1525712-2016-01557
• 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: 04/23/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FDX-MCG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2012
• 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