MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	50T-MAXX
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	Head Injury (1879); Pain (1994); Distress (2329); Depression (2361)
Date of Event	06/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The wheelchair seating system identified in this complaint was shipped by motion concepts to invacare (b)(4) on 31-mar-2016.Motion concepts was notified of the complaint on the 28th of february 2020.The alleged incident took place 20 months prior on the (b)(6) 2018.The complaint alleges that the back of the wheelchair seating system became suddenly unattached, causing the user to fall head first from the chair, resulting in physical and emotional injuries.Upon review of our production records, it was determined that a back support was not supplied or installed by motion concepts prior to delivery of the seating system.At the time of order, the 'omit back' option was selected on the system order form.Therefore, the back support involved in the alleged incident would have been purchased from a third-party manufacturer and installed onto the seating system by the dealer (or other third party) at a time subsequent to the delivery of the wheelchair.Motion concepts owner's manual includes safety warnings regarding the use of non-approved accessories.'risk of serious injury or damage - accessories designed by other manufacturers have not been tested and are not recommended for use with motion concepts products.'.
Event or Problem Description
The plaintiff was allegedly sitting in his wheelchair when the back part of the chair suddenly became unattached and caused the plaintiff to fall to the floor head first.The attorney is alleging the plaintiff had head, neck, shoulder, and arm injury and also suffered from stress, anxiety, depression.These injuries have allegedly caused and continued to cause the plaintiff pain, suffering, loss of enjoyment of life, loss of housekeeping capacity, permanent physical disability, loss of physical, mental, and emotional health, and loss of earnings, past and prospective.No further information was provided by the attorney.

• 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,
• MDR Report Key: 9873964
• Report Number: 9615350-2020-00003
• Device Sequence Number: 2951823
• Product Code: ITI
• UDI-Device Identifier: 00754014710362
• UDI-Public: 00754014710362
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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-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: 03/24/2020
• 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: Other; Disability