MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	50T-MAXX
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017, the system was shipped to (b)(6) health according to the end user specification.There have been no malfunctions reported to motion concepts on this seating system since 2017.But the system was hit by a car, while crossing a road, damaging the front rigging and the right arm pad and the end user contacted the dealer for the replacement parts.Dealer stated driver is at fault and nothing from the wheelchair caused this issue.Therefore, we believe this incident was not caused by a malfunction of the seating system.However, an injury might be involved in this incident so we consider it as a reportable.
Event or Problem Description
On (b)(6) 2018, motion concepts was informed by (b)(6) (motion concepts importer), that one of their dealer at (b)(6) ((b)(6) health), was notified of an incident that took place on (b)(6) 2018.The dealer reported that the system was hit by a car while crossing the road and they needed parts for replacement.Fortunately, it does not sound she was injured.Dealer stated that he needed the front rigging and arm pads for replacement and the incident is not because of any system malfunction.

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): MOTION CONCEPTS LP; 84 citation drive; unit 1-7; concord, ontario L4K3C 1; CA L4K3C1
• MDR Report Key: 7541994
• Report Number: 9615350-2018-00003
• Device Sequence Number: 19436111
• Product Code: ITI
• UDI-Device Identifier: 00754014710362
• UDI-Public: 00754014710362
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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: No Information
• Device Model Number: 50T-MAXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 94