MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDX SP2 BASE FOR MULTIPLE ACTUATOR SYSTEM W/ ULTRA LOW MAXX; POWERED WHEELCHAIR

Model Number	TDXSP2-MCG
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is being filed in an abundance of caution because in this specific instance the wheelchair happened to stop in the street, and though there was no allegation of injury or harm to the user, the user expressed that they were slightly scared due to the incident.The alleged malfunction of the wheelchair stopping/shutting down while driving in and of itself is not likely to cause/contribute to serious injury/illness or death.With regards to free wheel mode, when the motor locks are engaged, the wheelchair can be driven via the joystick and when the motor locks are disengaged, it allows for freewheeling for the wheelchair to be pushed manually.A corrective action has been initiated to further investigate motor/brake issues, however, it has not been confirmed if the reported event is the result of a malfunction and/or related to this corrective action.If additional information becomes available, a supplemental record will be filed.
Event or Problem Description
On a tdxsp2-mcg power wheelchair, the brake levers are spinning in circles and not catching/engaging from drive to free wheel mode.The user went over a bump and somehow the coupling switched to free wheel while in the middle of the street.A person got out of their car and helped push the user in the wheelchair onto the sidewalk.There was no injury to the user, however, they expressed they were slightly scared.

• Brand Name: TDX SP2 BASE FOR MULTIPLE ACTUATOR SYSTEM W/ ULTRA LOW MAXX
• Common Device Name: POWERED WHEELCHAIR
• 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: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 22160032
• Report Number: 1525712-2025-00007
• Device Sequence Number: 7484721
• Product Code: ITI
• UDI-Device Identifier: 00841447100966
• UDI-Public: 00841447100966
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TDXSP2-MCG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown