MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	45T-12L-RPSB-MAXX
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)
Health Effect - Clinical Codes	Abrasion (1689); Injury (2348)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This system was ordered by the dealer (b)(6) as per the end user specification.This is a rovi system that comes with a rovi joystick tube and quad link designed for the rnet and vr2 joystick type.After reviewing the pictures, it was clear that this chair was modified by the dealer because the pictures show that a joystick tube and a quad link from (third party manufacturer) was adapted to lower the joystick below the designed limit.In addition to that the third party manufactured quad link had been reconfigured in such a way that the joystick could be lowered further, therefore causing the joystick control knob to contact the arm pad resulting in the wheelchair movement.We advised the servicing dealer that they need to put the original equipment back on the system.
Event or Problem Description
On (b)(6) 2018, motion concepts was informed by (b)(6) (motion concepts importer), that one of their dealers at (b)(6), was notified of an incident that took place on (b)(6) 2018.The dealer reported that the end user got a cut on her calf while the end user's husband was trying to back her up from the table she was at.The joystick, which was retracted while her husband was backing her up, got activated that caused the system to turn and the center mount of the system ended up cutting her calf.Medical attention was need for the end user as there was bleeding on her calf.According to the dealer, the end user wants modification on the chair.

• 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: 7542038
• Report Number: 9615350-2018-00004
• Device Sequence Number: 1696687
• Product Code: ITI
• UDI-Device Identifier: 00754014710119
• UDI-Public: 754014710119
• 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: 45T-12L-RPSB-MAXX
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 88