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	Bone Fracture(s) (1870)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentioned system was shipped to (b)(4) (motion concepts distributor) on 08-may-2017 & was then sold to (b)(6) on (b)(6) 2017.The dealer stated that the incident is not because of any system malfunction.However, an injury has been involved in this incident so, we consider it as reportable event.
Event or Problem Description
On 21-feb-2020, motion concepts was notified by (b)(4) (motion concepts importer) that one of their dealers (b)(4 was notified of an incident that took place on (b)(6) 2020.The dealer reported that the system was struck by a public transport while trying to cross the road.Unfortunately, the system was tipped over on its back and the user was knocked out of the system and as per dealer he has unspecified fracture of lumbar vertebra.As of now the user is hospitalized and the dealer stated that 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 1-12; concord, ontario L4K 3 C1; CA L4K 3C1
• MDR Report Key: 9828918
• Report Number: 9615350-2020-00002
• Device Sequence Number: 743230
• Product Code: ITI
• UDI-Device Identifier: 00754014710065
• UDI-Public: 00754014710065
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: 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: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 45 YR
• Patient Weight: 47