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	Insufficient Information (4580)
Date of Event	02/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentioned system was shipped from motion concepts to medbloc (motion concepts usa importer/distributor), as per dealer requirements, on 22-jan-2025 and then was sold to national seating & mobility- urbandale, ia on (b)(6) 2025.The incident was not caused by a system malfunction.However, since an injury was involved, we consider this a reportable event.
Event or Problem Description
On february 24, 2025, medbloc (distributor) informed motion concepts lp about an incident involving one of our wheelchairs.The product had been sold to an end-user in the usa through the dealer national seating & mobility - urbandale, ia.According to the dealer, the wheelchair was involved in an automobile accident while the end-user was riding as a passenger.During the accident, the wheelchair collided with the vehicle's dashboard, resulting in a wrist injury for the end-user, who is planning to seek medical attention.Additionally, the joystick mount was damaged in the accident.At the time of the incident, the system had been in use for approximately one month.

• 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: 21518605
• Report Number: 9615350-2025-00001
• Device Sequence Number: 12856681
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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: 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: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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: Hospitalization
• Patient Sex: Female
• Patient Weight: 64 KG