MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	45T-12L-RESR-MAXX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject wheelchair system was shipped by motion concepts lp to (b)(4) the authorized u.S.Importer/distributor, on (b)(6) 2025, in fulfillment of a dealer order.The system was subsequently sold by (b)(4) to (b)(4) ((b)(6)) on (b)(6) 2025.Following notification of the incident, motion concepts lp reviewed the available information and advised the dealer that the wheelchair base should be replaced.The wheelchair base manufacturer was also notified of the event.Based on the information received, the reported incident resulted from a motor vehicle collision involving the wheelchair user and does not appear to be related to a malfunction, failure, or performance issue of the wheelchair system.No evidence has been identified to suggest that the device contributed to the occurrence of the event.However, because the incident resulted in a reported injury to the user while the device was in use, motion concepts lp has determined that the event is reportable in accordance with applicable regulatory requirements.
Event or Problem Description
On (b)(6) 2026, motion concepts lp was notified by its authorized distributor, (b)(4), of an incident involving a motion concepts wheelchair in the field.The distributor indicated that the wheelchair system had been sold to (b)(4) ((b)(6)), which is responsible for ongoing service and maintenance of the unit.According to the report, the consumer was operating her wheelchair and was stopped at an intersection awaiting the pedestrian signal to change.While the consumer was stationary, a vehicle making a right turn on a red light reportedly failed to yield or observe the consumer, resulting in a collision with the wheelchair user.As a result of the incident, the consumer sustained a contusion to the left arm secondary to impact from the vehicle.The consumer subsequently sought medical evaluation and treatment from an orthopedic physical therapist.

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): MOTION CONCEPTS LP; 505 cityview blvd; unit 1; vaughan, ontario L4H 0 L8; CA L4H 0L8
• Manufacturer (Section G): MOTION CONCEPTS LP; 505 cityview blvd; unit 1; vaughan, ontario L4H 0 L8,; CA L4H 0L8,
• Manufacturer Contact: dona bhamra ; 505 cityview blvd; unit 1; vaughan, ontario L4H 0-L8 ; CA L4H 0L8
• MDR Report Key: 25613547
• Report Number: 9615350-2026-00005
• Device Sequence Number: 13035004
• Product Code: ITI
• UDI-Device Identifier: 00754014710065
• UDI-Public: 00754014710065
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: 45T-12L-RESR-MAXX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 52 KG