MAUDE Adverse Event Report: INVACARE CORPORATION POWERED WHEELCHAIR SYSTEM

Model Number	INVACARE RX BASE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On july 7, 2025, (b)(4) (dealer) reported an incident to motion concepts lp involving a motion concepts wheelchair.According to the end-user's mother, the wheelchair's tire locked while the user was in the washroom and then suddenly released, causing the user to lunge forward at high speed.Her head struck a toilet roll dispenser, and she was admitted to the hospital for observation.A ct scan was performed, which showed no injuries, and she was discharged on (b)(6) 2025.The end-user's mother reported that this was the first occurrence of such a malfunction and also confirmed that she was not wearing the postural belt at the time of the incident.The dealer inspected the wheelchair on june 26, 2025, and confirmed that the malfunction occurred again during their inspection.It was also noted that the end-user has systemic juvenile rheumatoid arthritis and experiences delayed development and growth.
Additional Manufacturer Narrative
The reported powered wheelchair system was shipped by motion concepts to (b)(4) (dealer) in ontario, canada, on july 30, 2024, in accordance with the dealer's request.The powered base associated with the incident was manufactured by a third-party supplier and the manufacturer has been notified of this incident.The wheelchair was returned to motion concepts for evaluation and rework.During the evaluation, an intermittent issue with the base motors was identified as there was unexpected motor locking behavior.It was also noted that the end-user was not wearing the postural belt at the time of the incident, which contributed to the incident.Motion concepts includes the following warning in its owner's manual regarding postural belt use: 'warning! risk of serious injury or compromised user safety not wearing your postural belt could result in serious injury or compromised safety.· always wear your postural belt.Your postural belt helps reduce the possibility of a fall from the wheelchair.' to address the incident, motion concepts reworked the system, replacing both base drive motors.The caster assembly and headlight kit were also replaced as a courtesy.This incident was caused by a malfunction of a third-party manufactured product, not a motion concepts product.Since personal injury was involved, we consider this incident reportable.

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): INVACARE CORPORATION; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): INVACARE CORPORATION; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: ronald tucker ; 1200 taylor street; elyria, OH 44035 ; 4403296284
• MDR Report Key: 22733080
• Report Number: 9615350-2025-00005
• Device Sequence Number: 15700789
• Product Code: ITI
• UDI-Device Identifier: 00841447114581
• UDI-Public: 00841447114581
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K202379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair,Replace
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: INVACARE RX BASE
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 25 KG