MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	50T-RESR-MAXX
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Injury (2348); Loss of consciousness (2418)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentioned system was shipped from motion concepts to (b)(4) (motion concepts usa importer/distributor), as per dealer requirements, on 06-may-2020 and then was sold to (b)(6) on 15-may-2020.The dealer stated that the incident was caused when the end-user drove the wheelchair into the grass patch, for providing clearance for a cyclist on the sidewalk.While on grass patch, the mentioned system's right wheel came into contact with the in-ground water sprinkler system, which caused the system to spin and to tip over to end-users left side.After evaluating this incident, it is concluded that the issue was caused due to unintended inappropriate use of the wheelchair.Motion concepts have included warning statements on the owners manual for avoiding incidents similar to this.In the 'stability warnings' section, it has been stated that: "loss of traction or stability on rough or unstable terrain may cause damage, injury or death: · do not operate the wheelchair on rough or unstable terrain.This would include, but is not limited to areas of rock, gravel, sand, mulch, mud, uneven pavement, roots and similar conditions.· always be aware of your surroundings and conditions that might affect the stability and performance of the wheelchair." also, in the 'warning when driving your power wheelchair!' section, it has been stated that: "improper wheelchair operation may cause a loss of traction which can result in damage, serious injury or death: · do not make sudden direction changes at high speed.Allow the wheelchair to come to a full stop before changing direction.Loss of traction or stability on rough or unstable terrain may cause damage or serious injury: do not operate the wheelchair on rough or unstable terrain.This would include, but is not limited to areas of rock, gravel, sand, mulch, mud, uneven pavement, roots and similar conditions.Always be aware of surroundings & conditions that might affect the ability to operate the wheelchair." in addition to above, all the motion concepts wheelchair categories has passed the stability test before releasing on to the market.Therefore from the available information, it is concluded that the incident was not caused due to any system malfunction.For addressing this issue, replacement system will be provided to the end-user as she is not confident with her existing wheelchair.However, an injury was involved, so we consider this incident as reportable.
Event or Problem Description
On 06-jul-2020, motion concepts was notified by (b)(4) (motion concepts usa importer), that one of their dealers ((b)(4)) notified them of an incident that took place on (b)(6) 2020.The dealer stated that the end-user was driving through the sidewalk and when a cyclist came towards her, she moved her wheelchair to the grass for making clearance.Unfortunately, the right wheel came into contact with the in-ground sprinkler system, which caused the system to spin and tip over onto her left side.The end-user spent 4 days at (b)(6) trauma center as she was knocked out cold and also, suffered soft tissue damage.The end-user wants the system to be replaced as she is not confident with the existing system.

• 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: 10303893
• Report Number: 9615350-2020-00007
• Device Sequence Number: 2780324
• Product Code: ITI
• UDI-Device Identifier: 00754014710393
• UDI-Public: 00754014710393
• 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
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• 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: 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: Hospitalization
• Patient Weight: 105