BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-CORE MAG WHEEL ASSEMBLY

    MDR report key: 22883175 · Received August 25, 2025

    Report

    Report Number
    MW5175147
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    June 2, 2025
    Report Date
    August 11, 2025
    Manufacturer
    CUSTOM ENGINEERED WHEELS (CEW), INC.
    Product Code
    KNN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025 CLIENT REPORTED THE WHEEL ASSEMBLY ON HIS SUNRISE MEDICAL QUICKIE 5R WHEELCHAIR (SERIAL NUMBER (B)(6)) FAILED WHILE HE WAS ABOARD A FISHING BOAT. HE HEARD A LOUD POP BEFORE THE WHEEL ASSEMBLY (X-CORE MAG) EXPLODED. CAUSING A LARGE PIECE OF PLASTIC TO DETACH FROM THE WHEEL. THE DEBRIS PUNCTURED BOTH HIS SEAT UPHOLSTERY AND ROHO AIR CUSHION. THE CLIENT CONFIRMED NO INJURIES OCCURRED. THE MANUFACTURER SALES REPRESENTATIVE ((B)(4)) WAS NOTIFIED. SUBSEQUENT FOLLOW UP WITH THE MANUFACTURER INDICATED THE X-CORE MAG WHEELS ARE PRODUCED BY A THIRD- PARTY SUPPLIER AND ARE NOT MANUFACTURED BY SUNRISE MEDICAL, ALTHOUGH THEY ARE PART OF THE WHEELCHAIR ASSEMBLY. (B)(6) 2025- REPLACEMENT WHEELS AND NEW SEAT UPHOLSTERY INSTALLED. (B)(6) 2025- EMAIL FROM FACILITY STAFF TO MANUFACTURERS SALES REPRESENTATIVE (B)(4) REQUESTING FOLLOW UP WITH THE MANUFACTURER MANAGEMENT REGARDING THE EXPLODING TIRE INCIDENT. (B)(6) 2025- REPLY FROM THE MANUFACTURE SALES REPRESENTATIVE INDICATING SHE BELIEVES SOMEONE FROM THE MANUFACTURER WOULD CONTACT FACILITY STAFF TO ADDRESS THE FOLLOW UP QUESTIONS. (B)(6) 2025- E-MAIL FROM FACILITY STAFF TO MANUFACTURE SALES REPRESENTATIVE REQUESTING UPDATES. (B)(6) 2025- PHONE CALL FROM THE MANUFACTURER REGIONAL DIRECTOR (B)(4) CONFIRMING THE X-CORE MAG WHEELS ARE MANUFACTURED BY A THIRD-PARTY SUPPLIER, NOT THE MANUFACTURER. SHE COMMITTED T CONTACTING HER PRODUCT MANAGER (B)(4) TO DETERMINE THE SUPPLIER¿S IDENTITY. ADDITIONAL COMMENTS . ON-SITE EVALUATION DETERMINED THE WHEEL ASSEMBLY, SEAT UPHOLSTERY, AND ROHO CUSHION WERE NOT REPAIRABLE AND REQUIRED REPLACEMENT. PHOTOGRAPHS OF THE DAMAGE WERE TAKEN. MANUFACTURER SALES REPRESENTATIVE ADVISED CONTACTING MANUFACTURER CUSTOMER SERVICE FOR RESOLUTION. MANUFACTURER CUSTOMER SERVICE APPROVED A RETURN MERCHANDISE AUTHORIZATION FOR THE DAMAGED WHEEL AND SEAT UPHOLSTERY. FACILITY STAFF LEFT A VOICEMAIL FOR MANUFACTURER SALES REPRESENTATIVE REQUESTING INFORMATION ON THE PROCESS THE MANUFACTURERS FOLLOWS WHEN SUCH INCIDENTS OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291825 X-CORE MAG WHEEL ASSEMBLY COMPONENTS, WHEELCHAIR KNN CUSTOM ENGINEERED WHEELS (CEW), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male QUICKIE 5R WHEELCHAIR, SERIAL NUMBER: (B)(6), MFR: SUNRISE MEDICAL (US) LLC.