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

Model Number TDXSR

Device Problems Break (1069); Sticking (1597)

Patient Problem Alteration In Body Temperature (2682)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: custom power wheelchairs, controller/joystick/options, physical damage.Cable has exposed wires.Complaint of wires on the back of the chair got pinched was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: custom power wheelchairs, controller/joystick/options, physical damage.Cable has exposed wires.Dealer advised end user was stuck in elevate and shorted so could not lower.

• 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: 5169552
• MDR Text Key: 29258662
• Report Number: 1525712-2015-05014
• 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
• Type of Report: Initial
• Report Date: 09/25/2015

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: TDXSR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2015
• Initial Date FDA Received: 10/22/2015
• 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