MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	50T-RPSB-MAXX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018, the mentioned system was shipped to the dealer ((b)(6)), according to the end-user specification provided.The dealer stated that this system was involved in an automobile accident while riding on the parking lot.The other vehicle was backing up and hit the end-user's chair.There is no injury or device malfunction reported on this mentioned incident.It is also to be noted that there has never been any malfunction on this mentioned system, however, system was involved in this accident, so we consider it as a reportable event.
Event or Problem Description
On (b)(6) 2020, motion concepts lp was notified by medbloc inc.((b)(4)), that one of their dealer (numotion) notified them of an incident that took place on (b)(6) 2020.The dealer reported that the end-user was riding the wheelchair at the parking lot and a vehicle hit the end-user while backing up.The dealer also mentioned that there was no reported injury to the end-user and there was no device malfunction involved.

• 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
• MDR Report Key: 10303841
• Report Number: 9615350-2020-00006
• Device Sequence Number: 11458219
• Product Code: ITI
• UDI-Device Identifier: 00754014710416
• UDI-Public: 00754014710416
• 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): 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Model Number: 50T-RPSB-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: 07/21/2020
• 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: 126