MAUDE Adverse Event Report: INVACARE TAYLOR ST. TDXSP 2 HEAVY DUTY; POWERED WHEELCHAIR

Model Number NA:TDXSP2-MCG-HD

Device Problem Component Missing (2306)

Patient Problems Laceration(s) (1946); Damage to Ligament(s) (1952)

Event Type  Injury  

Manufacturer Narrative

During the initial assessment of the joystick, in the field, it was identified that the retaining pin on the joystick shaft was not centered as it should be.At that time, it was unknown if the pin location was related to the event.The joystick was returned to invacare for further evaluation, and no functional issues were identified.There were no unintended movement or communication issues observed during testing.Based on the evaluation findings, the location of the retaining pin did not contribute to the event.Since the alleged issue could not be reproduced, the underlying cause could not be determined.Further evaluation of the joystick is in process.It has been confirmed that a replacement joystick was installed on the power chair, and no further issues with the device have been reported.Should additional information become available, a supplemental record will be filed.

Event Description

While using a tdxsp2 powerchair, the end user engaged the joystick in a forward direction.Without warning, the chair suddenly lunged forward and then sharply to the right, hitting the door frame.This resulted in a laceration requiring stitches to his left leg and a swollen bruised foot on the right leg.

Event Description

While using a tdxsp2 powerchair, the end user engaged the joystick in a forward direction.Without warning, the chair suddenly lunged forward and then sharply to the right, hitting the door frame.This resulted in a laceration requiring stitches to his left leg and a swollen bruised foot on the right leg.

Manufacturer Narrative

Further details of the end users¿ injuries were received.He relates he was admitted to the va hospital for treatment of a torn mcl and other undefined knee/foot injuries.It was determined that he requires surgery for the torn mcl.Currently, he is unable to bear weight for transfers.The dealer has ordered a power module and remote cable as a preventative effort, but they have not been installed on the powerchair at this time.There have not been any further issues alleged with the powerchair.Additional information about the end users¿ injuries and powerchair have been requested; however, no further details have been provided.Should additional information become available, a supplemental record will be filed.

Manufacturer Narrative

The evaluation and testing of the returned electrical components (joystick, cable and power module) have been completed.The quality engineer was unable to reproduce the issue of unintended movement.These components were also examined by the supplier.They also did not find any issue with the joystick or electrical system that would contribute or cause the incident.Based on their examination, the positioning of the retaining clip pin did not affect the function of the remote.The position of the spring retainer was still fully restrained, and the drive performance of the joystick was unchanged.A follow up communication with the dealer confirmed there have been no further issues with the tdxsp2 power wheelchair since the electrical components were replaced.If additional information becomes available, this record will be updated accordingly.

Event Description

While using a tdxsp2 powerchair, the end user engaged the joystick in a forward direction.Without warning, the chair suddenly lunged forward and then sharply to the right, hitting the door frame.This resulted in a laceration requiring stitches to his left leg and a swollen bruised foot on the right leg.

• Brand Name: TDXSP 2 HEAVY DUTY
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria 44036 ; 8003336900
• MDR Report Key: 15330087
• MDR Text Key: 299039424
• Report Number: 1525712-2022-00007
• 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,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:TDXSP2-MCG-HD
• Device Catalogue Number: TDXSP2-MCG-HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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): Hospitalization; Required Intervention
• Patient Sex: Male