MATRX CUSHION

Description of Event or Problem

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.