MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	50T-MAXX
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This system was ordered by the dealer ((b)(4)), according to the end user specification.Front rigging of the system was changed from 70° swing away hangers, which he was using in his old chair, to power center mount with heel straps as there were leg issues for the end user in the past.Dealer also added calf straps to the calf pads to avoid incidents like this.Unfortunately, the end user wasn't using the calf straps and it seems that his feet were not properly supported by the heel straps at the time of event.The dealer has also reported that there was no malfunction of the chair.It is noted that the motion concepts user manual provided with this system, includes the following warning: "before operating your wheelchair, always ensure footplates/platforms are in their full down position and your feet are properly supported by the heel straps" however, in this case, this precaution was not followed by the end user.
Event or Problem Description
On 19-april-2018, motion concepts was notified by (b)(4) (motion concepts importer), that one of their dealers ((b)(4)) was notified of an incident that took place on (b)(6) 2018.The dealer reported that the end user's left foot slid off from the back-left corner of the footplate.Since he has no sensation in the lower extremity of his body, he continued to drive until he heard a snap, that he saw, it was on his ankle.As a result of this incident, there were 2 broken bones in left ankle.Power center mount front rigging with heel straps were used in the system as the end user had a history of legs issues on wheel chair.In addition to that, the dealer installed calf straps to the calf pad for the safety of the end user to avoid any adverse event.The dealer stated that the calf straps were not in use when this incident happened and the system did not malfunction.

• 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: 7465655
• Report Number: 9615350-2018-00002
• Device Sequence Number: 13478938
• Product Code: ITI
• UDI-Device Identifier: 00754014710362
• UDI-Public: 00754014710362
• 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): 04/26/2018

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: 50T-MAXX
• Was Device Available for Evaluation?: No
• 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: 04/26/2018
• 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: Other
• Patient Age: 62 YR
• Patient Weight: 75