MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	LC1918
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	Ulcer (2274)
Type of Reportable Event	Serious Injury
Event or Problem Description
On february 13, 2024, motion concepts lp received notification from medbloc inc.Regarding an incident involving a matrx cushion.A dealer in the usa (numotion, nashville, tn) reported an issue with a cushion being used by an end-user, alleging a gel leak that may have led to a pressure ulcer on the left hip of the user.Consequently, the end-user required debridement, wound vac treatment, and hospitalization.The alleged libra cushion was exchanged under warranty; however, the end-user is currently seeking a replacement with a roho cushion, following the recommendation of the physical therapist.Additionally, it was noted that the end-user, who has paraplegia, typically utilizes the wheelchair for approximately 12 hours per day.The date of the event is unknown.
Additional Manufacturer Narrative
The wheelchair was dispatched from motion concepts to medbloc (motion concepts usa importer/distributor) in accordance with dealer requirements on july 13, 2021, and subsequently sold to numotion, grand chute, wi on july 15, 2021.In february 2023, the dealer contacted our distributor to place an order for several components, among them a new libra cushion, which is the cushion involved in this incident.This cushion was delivered to the dealer on february 10, 2023, and replaced the original libra cushion in the wheelchair due to normal wear and tear.The purported cushion was returned to motion concepts on february 22, 2024, and upon evaluation, it was confirmed that the gel sac had a minor leak.It was observed that the leak was minimal, with gel still present inside the gel sac albeit at a reduced volume.Additionally, the evaluator observed that the secondary supplemental gel pad within the returned cushion, providing additional support to the end user, remained intact.After thoroughly examining all the information pertaining to this incident, motion concepts has concluded that the reported pressure ulcer does not appear to be the direct result of the cushion gel sac leaking.Evidence of a developing pressure ulcer would have been visible by an attendant or care giver during daily hygiene practices.Furthermore, the following warning statements have been outlined in the matrix libra cushion owner's manual.Section 4.0, care and maintenance, of the manual includes the following: 'warning! risk of injury or damage: do not continue to use this product if problems or damage are discovered.Corrective maintenance can be performed at or arranged through your service provider 4.1 inspection frequent visual inspection of all components, including upholstery materials, fluid sac, foam and any hardware or plastics, should be performed to identify any breakage, deformation, punctures, wear and tear or compression.Replace damaged/worn components if necessary".Also in section 2.1, general safety guidelines, of the owner's manual includes the following: "warning! risk of serious injury or damage wheelchair users are at increased risk of developing pressure related injuries.Skin condition should be checked frequently after the installation of any new seating system".The incident did not stem from a malfunction within the matrx cushion.However, given the involvement of a personal injury, motion concepts deems this incident reportable.

• 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: 18849774
• Report Number: 9615350-2024-00001
• Device Sequence Number: 20716089
• Product Code: KNN
• UDI-Device Identifier: 07540147000998
• UDI-Public: 7540147000998
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

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: LC1918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 88 KG