MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	45BT-MAXX
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Fall (1848); Ulcer (2274); Anxiety (2328); Depression (2361)
Date of Event	10/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mentioned wheelchair system (system s/n: (b)(4)) was sold to motion specialties-cep on (b)(6) 2016, for an end-user named (b)(6).This wheelchair system was uniquely configured to meet the requirements of this particular end-user at the time of manufacture.After reviewing the details provided by garett harper (counsel of motion specialties and motion gp inc), the mentioned system was resold to the current end-user (w.D.G) on (b)(6) 2018, without notifying motion concepts.We compared the measurements of both users, which are utilized to properly and safely configure the seating system and determined that these measurements were different from each other.It was also noted that the power wheelchair base onto which motion concepts installed the original seating system was also changed to a different model wheelchair base.The wheelchair base for donna smith was a quantum q6 edge hd base with serial number: (b)(4); whereas the base reported in the incident indicates a base with serial number: (b)(4).Following our internal investigation, it appears that our original motion concepts seating system would have required a significant reconfiguration in order to properly fit the new (current) end-user, and to safely interface onto a different model wheelchair power base.Any changes or modifications performed by the dealer, to the original wheelchair system, were conducted without prior knowledge, consultation, or approval from motion concepts.As a personal injury was involved, motion concepts does consider this incident to be reportable.
Event or Problem Description
On 02-feb-2022, (b)(4), who is representing motion specialties & motion gp emailed, and notified us about an incident that took place on (b)(6) 2018.As per the plaintiff's claim, the reported wheelchair was purchased by the end-user in 2018 and on (b)(6) 2018, the wheelchair malfunctioned and the locking mechanism holding the chair in seated position failed, causing the end-user fell out from the wheelchair by hitting his head and left shoulder.As the end-user was immobile and requires 24 hours care, he was bed ridden without the use of functioning wheelchair for unspecified time.The plaintiff's claim also mentions that the end-user developed a pressure ulcer from having to use his old wheelchair as the seat of this old wheelchair was worn and ineffective.Due to the ulcer, the end-user's relative has to do further difficult physical care and the end-user suffered depression, anxiety and 15-month bedrest without wheelchair, with further medical attention needed for his ulcer and other head/shoulder injury.

• 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: 13652820
• Report Number: 9615350-2022-00001
• Device Sequence Number: 17626443
• Product Code: ITI
• UDI-Device Identifier: 00754014710423
• UDI-Public: 00754014710423
• Combination Product (Y/N): N
• PMA/510(K) Number: K021264
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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: 45BT-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: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 125 KG