MAUDE Adverse Event Report: CLINTON RIVER MEDICAL PRODUCTS LLC TAILWIND POWER ASSIST MANUAL WHEELCHAIR

Device Problems Break (1069); Product Quality Problem (1506); Battery Problem (2885); Device Operates Differently Than Expected (2913)

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

Event Date 08/18/2016

Event Type  malfunction  

Event Description

My wheelchair has been broken more than i have been able to use it.(b)(6)medical knows there are quality issues with their drive trains, but they continue to sell their products.Their batteries malfunction specifically going down a hill causing the chair to power off and go out of control.I have had to crash into a railing multiple times to stop myself from being flipped out of my chair.I have had multiple batteries sent to me and about 6 drive trains replaced, and the problems continue to persist.This affects every aspect of my life, work, play, social, etc.For a new chair paid for by health insurance that is supposed to keep me independent, this has seriously affected my life.I have an extensive text message with the (b)(6) representative from (b)(6) over the past year documenting the issues i have had.Email me at (b)(6) and i can provide this text message to you as well as other important emails and documentation i have regarding this.

• Brand Name: TAILWIND POWER ASSIST MANUAL WHEELCHAIR
• Type of Device: TAILWIND POWER ASSIST MANUAL WHEELCHAIR
• Manufacturer (Section D): CLINTON RIVER MEDICAL PRODUCTS LLC
• MDR Report Key: 6614086
• MDR Text Key: 76848207
• Report Number: MW5070171
• Device Sequence Number: 1
• Product Code: ITI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 240