MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX; WHEELCHAIR, POWERED

Model Number TDXSPREE-CG

Device Problem Sticking (1597)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.  .

Event Description

Tbm states that both front locking gas cylinders get hung up in the air when going over a threshold.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The original complaint issue was confirmed.The result of the evaluation was that the wheelchair was not configured correctly.A joystick was not returned with the chair; however, when a joystick was added and configured correctly, the chair was functional.Additionally, error codes indicated that the controller had been replaced at some point.

Event Description

Tbm states that both front locking gas cylinders get hung up in the air when going over a threshold.

• Brand Name: TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX
• 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: 5146745
• MDR Text Key: 28634304
• Report Number: 1525712-2015-04841
• 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
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 12/21/2015

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: TDXSPREE-CG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2015
• 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