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

Model Number TDXSP-CG

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: custom power wheelchairs.Charger, smell/odor issue.Unit operates correctly.Unit has a smell when operating.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed with respect to the alleged issue of an abnormal odor emanating from the 8 amp cte battery charger in question.The complaint with respect to the charger emitting any smoke was not confirmed, and none was observed during the evaluation.An inspection of the internal components of the charger suggested that on of the capacitors may have failed.Despite that, the charger functioned to adequately charge the batteries in the test set-up that was utilized during the evaluation.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Dealer was at the consumers house when the user took the unused cte battery charger out of its original packaging.User plugged the joystick charger in and then plugged into the wall and immediately saw a puff of white smoke which the smell was like a chemical.Dealer immediately unplugged from the chair then the wall.No flames, just smoke.No injuries to report.

• 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: 5596990
• MDR Text Key: 44078204
• Report Number: 1525712-2016-01181
• 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: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TDXSP-CG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2016
• 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