MAUDE Adverse Event Report: INVACARE TAYLOR STREET MECHANICAL (MANUAL) WHEELCHAIR; 890.3850

Model Number PATRIOT

Device Problems Use of Device Problem (1670); Device Tipped Over (2589); Mechanics Altered (2984)

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

Event Type  malfunction  

Event Description

Dealer advised end-user stated chair was tipping over.Dealer went to home and found end-user had added a one piece metal plate that goes from one footrest to the other.End-user advised it was altered due to she would have broken footplates and can not have her feet that far back.Dealer sat in chair and advised when leaned forward chair tips forward due to piece added on lightweight chair.Dealer advised removed plate and chair is fine, no injury, dealer could not provide any further information.(b)(4).

• Brand Name: MECHANICAL (MANUAL) WHEELCHAIR
• Type of Device: 890.3850
• 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: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3976918
• MDR Text Key: 4637771
• Report Number: 1525712-2014-04279
• Device Sequence Number: 1
• Product Code: IOR
• 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: 06/30/2014

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: PATRIOT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 08/04/2014
• 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