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 Problem Smoking (1585)

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

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

The joystick was returned for evaluation; however, it was unable to be tested, so the complaint of it smoking could not be verified.Per the expanded evaluation report, the pcb had a u5 and c45 failure, which could have caused the unit to smoke, but no smoke was observed.The joystick would not power up, so functional testing could not be done.Should additional information become available, a supplemental record will be filed.

Event Description

Dealer is stating that the unit was riding fine, and he stopped and plugged the off board charger into the chair, and after 10 minutes the joystick started to smoke internally.

• 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: 5768529
• MDR Text Key: 49491932
• Report Number: 1525712-2016-02393
• 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: Initial
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• 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