MAUDE Adverse Event Report: MOTION CONCEPTS LP MATRX CUSHION; WHEELCHAIR COMPONENT

Model Number	MA2418-VI-HD
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07-apr-2026, nsm (the dealer) notified motion concepts lp of an incident involving an invacare matrx vi hd cushion.According to the information provided, the cushion was breaking down during use.The foam sections, which are secured by velcro strapping, were reported to slit apart when the end user is seated, and the gel well was observed to fold over, creating areas of increased pressure.As a result, the end user developed skin breakdown (wounds) on the backs of her thighs.Photographs of the cushion condition were provided by the dealer.
Additional Manufacturer Narrative
The reported invacare matrx vi hd cushion was distributed by motion concepts lp to nsm red deer on november 12, 2024, in accordance with dealer requirements.The dealer reported that, during use, the foam sections of the cushion secured by hook-and-loop (velcro) fasteners appeared to separate, and the gel well was observed to fold, resulting in localized areas of increased pressure.Motion concepts conducted an evaluation based on photographic evidence provided by the dealer.The review determined that the device had been modified from its original, cleared configuration.Specifically, the cushion had been altered to incorporate a fluid sac not included in the original product design, and the reinforcing strips had been repositioned to secure the added component.These modifications were not part of the device design, labeling, or intended use, and were not communicated to motion concepts.The identified modifications are considered to have adversely affected the structural integrity and intended pressure redistribution performance of the device.The subject cushion is not designed or validated for use with additional fluid sac components.In accordance with company policy, devices modified outside of original specifications are not eligible for warranty coverage.However, a one-time goodwill replacement of the cushion, in its original configuration, was provided to the customer on (b)(6) 2026.The customer was informed that the reported issue was attributable to the unauthorized modification involving the addition of a fluid sac.Based on the available information and evaluation, the reported issue is attributed to user modification of the device, specifically the addition of a non-original fluid sac and alteration of structural components.No device malfunction in the original, unmodified configuration could be confirmed.However, as a patient injury was reported, this event is considered reportable under fda mdr requirements.

• Brand Name: MATRX CUSHION
• Common Device Name: WHEELCHAIR COMPONENT
• Manufacturer (Section D): MOTION CONCEPTS LP; 505 cityview blvd; unit 1; vaughan, ontario L4H 0 L8; CA L4H 0L8
• Manufacturer (Section G): MOTION CONCEPTS LP; 505 cityview blvd; unit 1; vaughan, ontario L4H 0 L8; CA L4H 0L8
• Manufacturer Contact: dona bhamra ; 505 cityview blvd; unit 1; vaughan, ontario L4H 0-L8 ; CA L4H 0L8
• MDR Report Key: 25081930
• Report Number: 9615350-2026-00004
• Device Sequence Number: 18785221
• Product Code: IMP
• UDI-Device Identifier: 07540147000073
• UDI-Public: 07540147000073
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: MA2418-VI-HD
• 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: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 195 KG