MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDXSP WET BLACK EURO NARROW BASE W/ 18-1 SSD GEAR BOX; WHEELCHAIR, POWERED

Model Number TDXSP-MCG

Device Problems Moisture Damage (1405); Smoking (1585); Component Missing (2306)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Provider states that the user got caught in the rain with their chair and when they were out of the rain, they plugged their joystick in when it was still wet.Consumer advised provider that they saw smoke come out of the joystick when they plugged it in wet.Provider states that the rubber cover on the front of the joystick for the sd card is missing and water may have gotten in this area as well.No additional information provided.

• Brand Name: TDXSP WET BLACK EURO NARROW BASE W/ 18-1 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: karen loughren ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4336342
• MDR Text Key: 5203304
• Report Number: 1525712-2014-07988
• 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: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• 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?: No
• Date Manufacturer Received: 10/28/2014
• 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