MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	50T-RESR-MAXX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2020
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 18-sep-2019 and then was sold to national seating & mobility, (b)(4) on 01-oct-2019.The dealer did not report any system malfunctions but stated that, no injury was involved during this incident.However, as the incident involves motion concepts system, we considered this incident reportable.
Event or Problem Description
On 26-oct-2020, motion concepts lp was notified by medbloc inc.(motion concepts importer), that one of their dealers (national seating & mobility, (b)(4)) informed them of an incident that took place on (b)(6) 2020.The dealer reported that the end user was hit by a car and there was no injury reported on the end-user, but the wheelchair needs to replace the footplate assembly as it was damaged during the accident.

• 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: 10886986
• Report Number: 9615350-2020-00012
• Device Sequence Number: 16867672
• Product Code: ITI
• UDI-Device Identifier: 00754014710393
• UDI-Public: 00754014710393
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: Lay User/Patient
• Device Model Number: 50T-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: 11/23/2020
• 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: Other
• Patient Weight: 89