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

Model Number TDXSP-MCG

Device Problems Crack (1135); Torn Material (3024)

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

Event Type  malfunction  

Event Description

It was reported by caller that the bolt that holds on the front rigging of the (b)(4) power chair is completely stripped.The caller states that the welded bracket that mounts the moving part of the front riggings have cracked at the weld that connects it.No further information available.

• 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 44036 ; 8003336900
• MDR Report Key: 4502281
• MDR Text Key: 5446786
• Report Number: 1525712-2015-01101
• 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: Other
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TDXSP-MCG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2015
• 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