MAUDE Adverse Event Report: INVACARE TAYLOR ST. AVIVA STORM RX; POWERED WHEELCHAIR

Model Number	NA:SRX-20MP
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was confirmed that the chair had a functioning seat positioning strap; however, the end user was not wearing the strap at the time of the incident due to being in process of transferring from the chair to the toilet.They didn¿t mention the system displaying any error codes.This was the first time the issue ever happened.The device was returned to motion concepts for service.Their technician test drove the chair and mentioned that it was not driving as needed and was having sudden movements.The motors were replaced.Motion concepts qc team tested the reworked system, and the system was working as required.The device was serviced and is now back out with the end user.The motors from the chair were scrapped after the service.A return of the device or related components is no longer expected.The root cause of the motors or system not operating as intended is unknown.The owner's manual for this device (part # 60127229-b) includes: warning-risk of serious injury or damage.Improper transfer techniques may cause serious injury or damage.Before attempting transfers, consult a health care professional to determine proper transfer techniques for the user and type of wheelchair.
Event or Problem Description
The initially alleged incident included: the client was ejected from a chair while driving, not wearing a seat strap.The dealer's technician went and diagnosed the chair.The right-side motor will not release into manual.The left side motor rotates, then gets stuck and jerks forward.Further details received provided: the user was transferring onto toilet; she has to move the chair out of the way, it lunged forward causing her to fall off the toilet and hit her head on toilet roll.

• Brand Name: AVIVA STORM RX
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 22945047
• Report Number: 1525712-2025-00010
• Device Sequence Number: 9676471
• Product Code: ITI
• UDI-Device Identifier: 00841447114581
• UDI-Public: 00841447114581
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: NA:SRX-20MP
• Device Catalogue Number: SRX-20MP
• 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: 08/06/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 25 KG