MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	45T-12L-MAXX
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On october 15, 2024, medbloc (distributor) notified motion concepts lp of an incident involving one of our wheelchairs.The product had been sold to the end-user in the usa by a dealer, american seating & mobility in (b)(6), who was also responsible for its maintenance.The dealer had installed a third-party head array on the wheelchair.According to the end-user, while using the wheelchair in an office room, the head array unexpectedly activated, causing the wheelchair to accelerate toward a desk.As a result, the end-user sustained bruising and scratches on the left leg but did not require medical assistance.The system had been in use for approximately four months at the time of the incident.
Additional Manufacturer Narrative
On may 31, 2024, the wheelchair was shipped from motion concepts to medbloc, the u.S.Distributor, based on dealer specifications.(b)(6).The dealer installed a third-party head array on the wheelchair, which had been in use for approximately four months at the time of the reported incident.The head array manufacturer was first notified of the incident by the end-user.On november 12, 2024, the system was returned to motion concepts for evaluation and rework.Upon inspection, it was found that the wheelchair was not cleaned, some cables were unplugged, the head array was nonfunctional, and the batteries had been disconnected from the system.These observations suggest that the dealer may have attempted rework on the wheelchair before returning it.Because the system was not returned in its original condition, an accurate assessment could not be completed and attempts to replicate the reported issue were unsuccessful due to the nonfunctional head array.We informed the dealer of these findings and recommended they refrain from further rework if motion concepts requests a return for evaluation.To resolve the incident, we will clean, rework, and thoroughly test the system before returning it to the customer.This incident was not caused by a malfunction of a motion concepts product, but rather by a third-party head array installed on the wheelchair.Since the incident involved personal injury, we consider it reportable.

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): MOTION CONCEPTS LP; 84 citation drive; unit 1 - 12; concord, on L4K 3 C1; CA L4K 3C1
• Manufacturer (Section G): MOTION CONCEPTS LP; 84 citation drive; unit 1 -12; concord, on L4K 3 C1; CA L4K 3C1
• Manufacturer Contact: dona bhamra ; 84 citation drive; unit 1 -12; concord, on L4K3C-1 ; CA L4K3C1
• MDR Report Key: 20689312
• Report Number: 9615350-2024-00004
• Device Sequence Number: 7230098
• Product Code: ITI
• UDI-Device Identifier: 00754014710034
• UDI-Public: 00754014710034
• 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: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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-MAXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 79 KG