MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	RS-12L-MAXX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Bone Fracture(s) (1870)
Date of Event	09/23/2022
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, (b)(4).The cause of this incident has been already confirmed from the end-user incident description, which is not due to any system malfunction, but an unintended/accidental slip of arms to the speed button, that steered the wheelchair to left side, when the system was over the lip of the ramp.To address this incident, motion cocnepts were informed that the system will be returned back to the dealer for evaluation and repair.The incident occurred not due to motion concepts system malfunction but, as a personal injury was involved, motion concepts consider this incident to be reportable.
Event or Problem Description
On (b)(6) 2022, motion concepts lp was notified by medbloc inc., that one of the dealers in usa (numotion - omaha, ne) informed them of an incident that was related to a motion concepts wheelchair.They notified that the end-user was exiting the van by going down on a ramp in her wheelchair, when the wheelchair moved to the left side near the lip of the ramp.The end-user and the wheelchair fell on to the garage cement when the wheelchair went over the lip of the ramp.The dealer also reported that the end-user must have accidently hit the speed button, while exiting the ramp, which made her lose control over the wheelchair.The end-user's left leg had scraped elbow, fractured femur and tibia on knee and broken plateau.They also reported that the end-user had pain in right shin and bruise in right foot and ankle due to this incident.

• 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
• Manufacturer (Section G): MOTION CONCEPTS LP; 84 citation drive; unit 1 -12; concord, ontario L4K 3 C1; CA L4K 3C1
• Manufacturer Contact: dona bhamra ; 84 citation drive; unit 1 -12; concord, ontario L4K 3-C1, ; CA L4K 3C1,
• MDR Report Key: 15789175
• Report Number: 9615350-2022-00009
• Device Sequence Number: 14841067
• Product Code: ITI
• UDI-Device Identifier: 00754014711024
• UDI-Public: 00754014711024
• 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
• Type of Report: Initial
• Report Date (Section B): 11/14/2022

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: RS-12L-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: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 68 KG