MAUDE Adverse Event Report: INVACARE TAYOLR STREET TDX SP2 BASE FOR REHAB SEATING; WHEELCHAIR, POWERED

Model Number NA:TDXSP2

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2022

Event Type  malfunction  

Manufacturer Narrative

This record is being filed in an abundance of caution.Invacare was made aware of this event that occurred in finland with a tdx-sp2 wheelchair.This record was created due to the u s.Manufactured tdxsp2 being similar in design and would likely to have the same adverse outcome as this event.Invacare germany has requested further information and the product for investigation.However, they have been informed that it cannot be sent back for further investigations as it is constantly in use.The hospital technician tested the joystick and couldn¿t duplicate the issue, but they replaced it as a precaution.If additional information becomes available a follow-up will be filed.

Event Description

The patient was in the shower and the assistant and was returning the patient from the shower chair to the 6-year-old tdxsp2 power wheelchair with a rem24 remote.When moving the device, the assistant had already let go of the remote and the device continued to travel.Running in to the assistant hurting her legs and knees.

• Brand Name: TDX SP2 BASE FOR REHAB SEATING
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYOLR 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: 15570777
• MDR Text Key: 306700304
• Report Number: 1525712-2022-00009
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA:TDXSP2
• Device Catalogue Number: TDXSP2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• 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