MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	45T-12L-RESR-MAXX
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Difficult to Maintain (3134)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentioned system was shipped from motion concepts to (b)(6), as per dealer requirements, on (b)(6) 2019 and then was sold to (b)(6) health care, (b)(6).On (b)(6) 2019.But the wheelchair was maintained by (b)(6).The dealer reported that the end user got pressure sores on her hip and bottom of her heel that was in a footbox, as the cushion on the seating system slipped forward.During the evaluation, it was also determined that the motion concepts did not provide the reported cushion or the footbox, which caused the unfortunate incident.Those were third party items, which were added to the seating system by the dealer.It was also noted that the dealer (b)(6), did not fix the issue when the issue was identified during the maintenance, and they did not contact motion concepts or our importer for resolving the issue.So, 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.
Event or Problem Description
On (b)(6) 2022, (b)(6) was notified by invacare cooperation, that one of the dealers in (b)(6) informed them of an incident that was related to a motion concepts wheelchair.The wheelchair was sold to (b)(6) health care (b)(6) but (b)(6) was maintaining it.They notified that the cushion on the system slipped forward, and the end user got pressure sores on her hip and bottom of her heel that was in a footbox.The dealer also reported that the end-user had to call her healthcare person to check for the pressure sores and confirmed that the pressure sores were developed gradually, as the dealer did not know how to fix the wheelchair when the issue was detected.Motion concepts was never notified about the issue until the incident was reported.

• 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 ; CA
• Manufacturer Contact: dona bhamra ; 84 citation drive; unit 1 -12; concord, ontario L4K 3-C1 ; CA L4K 3C1
• MDR Report Key: 14719369
• Report Number: 9615350-2022-00004
• Device Sequence Number: 11329053
• 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: Repair
• Type of Report: Initial
• Report Date (Section B): 06/16/2022

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: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• 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: Female
• Patient Weight: 75 KG