MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	45T-12L-RESR-MAXX
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Bone Fracture(s) (1870)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject wheelchair system was shipped by motion concepts lp to medbloc, the motion concepts u.S.Importer/distributor, on (b)(6) 2020, in accordance with a dealer order.The system was subsequently sold by medbloc to numotion (aurora, co) on (b)(6) 2020.A review of the device history indicates that the system was originally supplied with a 4-way push button switch, which was later replaced with a 4-way touch switch on (b)(6) 2025.Following notification of the reported incident, the end-user's husband requested replacement components, including a 4-way push button switch and a splitter.These components were subsequently shipped by motion concepts.The end-user's husband also reported that the bathroom sink may have inadvertently activated the device switch.Motion concepts conducted a review of available complaint data and determined that this is the first reported occurrence of a similar issue.To facilitate further evaluation, motion concepts requested the return of the subject device.However, the product has not been received as of (b)(6) 2026.Based on the information available at this time, a device malfunction cannot be confirmed.Given the report that the bathroom sink may have inadvertently triggered the device switch, the incident may have been the result of unintentional use error.However, as the incident involved a motion concepts wheelchair and resulted in user injury, this report is being submitted in accordance with mdr reporting requirements.If the subject device is returned and subsequent evaluation impacts the current assessment, a follow-up report will be submitted to the fda.
Event or Problem Description
On march 11, 2026, motion concepts lp was notified by its authorized distributor, medbloc, of an incident involving a motion concepts wheelchair in the field.The distributor indicated that the wheelchair system had been sold to numotion (aurora, co), which is responsible for ongoing service and maintenance of the unit.According to the report, the end-user was operating the wheelchair and was maneuvering the device underneath a bathroom sink at the time of the incident.During this activity, an unintended activation of the power leg rest occurred.It was reported by the end-user's husband that contact with the bathroom sink may have inadvertently activated a device switch.As a result of the unintended movement, the end-user's left foot made forceful contact with a wall, leading to a fractured left ankle and significant bruising to the toes on the left foot.The patient sought emergency medical care, where a three-way splint was applied.She was subsequently transferred to a local hospital for further evaluation and treatment and remained hospitalized for approximately three days.

• 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: 24815972
• Report Number: 9615350-2026-00003
• Device Sequence Number: 17645346
• 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): 04/08/2026

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: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2020
• 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: 79 KG