MAUDE Adverse Event Report: INVACARE TAYLOR STREET INVACARE TDX SP POWER WHEELCHAIR; WHEELCHAIR, POWERED

Model Number TDXSP-CG

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The tbm and provider were contacted for additional information regarding the event.They stated that the chair was turned off and was not plugged in at the time of the incident.They advised that the fire did not go out on its own; rather, it had to be extinguished.They stated that the fire was mostly contained to the battery area.Photographs were provided showing charring to the battery, battery harness, battery box, and rear shroud.The front shroud exhibited slight discoloration/deformation.There did not appear to be any damage to the battery cable.While evaluating the device, the provider's technician discovered an aftermarket jumper clamp in the battery compartment.The purpose of the clamp and whether it contributed to the event could not be verified.The provider suspects that the clamp was being used to power an external device using the chair's battery.However, this theory could not be proven, and the patient would not admit to doing so.The tdxsp user manual warns, "use of non-invacare accessories may result in serious injury or damage.Invacare products are specifically designed and manufactured for use in conjunction with invacare accessories.Accessories designed by other manufacturers have not been tested by invacare and are not recommended for use with invacare products.Do not use non-invacare accessories." the provider advised that they informed the patient they would not service the chair unless it was first returned to invacare for inspection.The patient rejected that offer and requested that the chair be sent back to them.Therefore, no further investigation can be conducted.The underlying cause of the alleged issue is unconfirmed.A product malfunction has not been verified.It should be noted that the chair has exceeded its expected life of 5 years.

Event Description

An invacare tbm (territory business manager) reported that a tdxsp-cg power chair was unoccupied in the corner of a room at a private residence when it started smoking and caught fire.There was no allegation of property damage or injury.

• Brand Name: INVACARE TDX SP POWER WHEELCHAIR
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 10754375
• MDR Text Key: 213626095
• Report Number: 1525712-2020-00024
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TDXSP-CG
• Device Catalogue Number: TDXSP-CG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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