MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDXSP FOR FORMULA CG; WHEELCHAIR, POWERED

Model Number NA:TDXSP-MCG

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

This report is being filed in an abundance of caution.  invacare was notified by an insurance representative that an invacare tdxsp-mcg power chair was in a room where a fire originated.  the cause of the fire continues to be undetermined, but the wheelchair causing or contributing to the incident cannot be ruled out at this time.Invacare has requested to be part of any inspections that take place.Should additional information become available, a supplemental record will be filed.

Event Description

Received a letter from pekin insurance claims person.The letter described a house fire where the origin was in a bedroom.A tdxsp-mcg was reportedly in the room at the time of the fire.

Manufacturer Narrative

The fire scene was visited by invacare representatives and other experts.It was noted there was fire damage to the upper portion of the chair while the wheels remained intact.It was determined that the wheelchair was not the cause of the fire and counsel for the homeowners¿ insurance indicated there was no need for further examination of the wheelchair.An old fan is believed to be the cause of the fire.Based on the final report there is no malfunction alleged, malfunction was selected in because it is a mandatory field.

Event Description

Received a letter from (b)(6) insurance claims person.The letter described a house fire where the origin was in a bedroom.A tdxsp-mcg was reportedly in the room at the time of the fire.

• Brand Name: TDXSP FOR FORMULA CG
• 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: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 7918316
• MDR Text Key: 122018981
• Report Number: 1525712-2018-00046
• 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,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:TDXSP-MCG
• Device Catalogue Number: TDXSP-MCG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• 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