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	Bruise/Contusion (1754)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, motion concepts lp was notified by (b)(4), that one of the dealers in usa (b)(4) informed them of an incident that was related to a motion concepts wheelchair.They notified that the end-user was driving his wheelchair alongside an inground swimming pool at his apartment complex and his arms slipped which caused him to steer the joystick to the right into the four feet deep shallow end of the pool.They also reported that the end-user and the system was under water for around 10 seconds and his friends, who were with him at the time of the incident, got into the pool and got the end-user and the system out from pool.The end-user had some bruising on his chin, elbow, and knees due to this incident.
Additional Manufacturer Narrative
The mentioned system was shipped from motion concepts to (b)(4), as per dealer requirements, on 09-mar-2022 and then was sold to (b)(4) on 15-mar-2022.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, that steered the joystick and the system to the pool.As the mentioned system has stopped working after the incident, the dealer returned the wheelchair back from the end-user for evaluation.Motion concepts has informed the dealer that all the electrical and mechanical components in the system needs to be replaced, as it all went under water or else it would be better and safe to replace the entire system.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.

• 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: 15428344
• Report Number: 9615350-2022-00007
• Device Sequence Number: 12642975
• Product Code: ITI
• UDI-Device Identifier: 00754014710065
• UDI-Public: 00754014710065
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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: 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: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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 Sex: Male