MAUDE Adverse Event Report: INVACARE TAYLOR STREET POWERED WHEELCHAIR; 890.3860

Model Number TDXSIV-2

Device Problem Charging Problem (2892)

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

Event Date 08/01/2014

Event Type  malfunction  

Event Description

Customer has replaced 8 - 10 pair of batteries.The first set of batteries was within 6 months of purchasing the chair.She has paid for all the batteries.Consumer also states that her batteries are not holding a charge.She used to be able to work a 10 hr.Shift on one battery charge, but now is only getting 6 to 8 hrs.On an overnight charge.Consumer states that when the batteries get down to one green light, the batteries only last a few minutes before they die.

• Brand Name: POWERED WHEELCHAIR
• Type of Device: 890.3860
• 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: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4111047
• MDR Text Key: 4764311
• Report Number: 1525712-2014-06214
• 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: Patient
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TDXSIV-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2014
• 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