BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE QXI

    MDR report key: 22768473 · Received August 11, 2025

    Report

    Report Number
    9616084-2025-00087
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    June 25, 2025
    Report Date
    August 10, 2025
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K072153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BACKGROUND INFORMATION: QUICKIE QXI WHEELCHAIR OWNER'S MANUAL STATES: "WARNING: THE OWNER OF THIS CHAIR IS RESPONSIBLE FOR MAKING SURE THAT IT HAS BEEN SETUP AND ADJUSTED BY A TRAINED SERVICE PROFESSIONAL UNDER THE ADVICE OF A HEALTHCARE ADVISOR. THE CHAIR MY REQUIRE PERIODIC SAFETY AND FUNCTION CHECKS OR CERTAIN IN-USE ADJUSTMENTS THAT MAY BE PERFORMED BY THE OWNER OR CAREGIVER." THE OWNER'S MANUAL FOR THE QUICKIE QXI PROVIDES A SAFETY CHECKLIST. THIS CHECKLIST STATES THAT THE CASTERS SHOULD BE CHECKED EVERY 3 MONTHS; FRAME CAMBER TUBES AND CROSS BRACE: EVERY 6 MONTHS; AND THE CHAIR SHOULD BE SERVICED ANNUALLY BY AN AUTHORIZED DEALER. THE CHAIR HAS BEEN IN USE FOR OVER 5 YEARS. DISCUSSION: IN EVALUATING THE COMPLAINT, THE DEALER STATED THAT THE END USER REPORTED THAT ON (B)(6) 2025, THE LEFT SIDE OF THE CASTER PLATE HARDWARE / LOWER BOLT BROKE DURING USAGE IN THE HOME. THIS REPORTEDLY CAUSED THE CHAIR TO PIVOT AND THE END USER TO FALL OUT OF CHAIR WHICH THEN REPORTEDLY CAUSED TWO FRACTURES TO PELVIC AND A BROKEN SHOULDER. THE END USER IS CURRENTLY IN (B)(6) HOSPITAL. CURRENTLY END USER WAS STILL ADMITTED AS OF THE DATE OF THE INITIAL REPORT, (B)(6) 2025. ACCORDING TO THE DEALER THE WHEELCHAIR IS CURRENTLY NOT IN USE. THE DEALER STATES THE END USER RECEIVED INJURIES AND HAS BEEN TRANSPORTED TO THE HOSPITAL FOR FURTHER EVALUATION. THE END USER WAS STILL HOSPITALIZED AT THE TIME OF INITIAL REPORTING. NO ADDITIONAL INFORMATION IS KNOWN AS TO THE STATUS OF THE END USER. CONCLUSION: IN CONCLUSION, THE DHR FOR THE DEVICE WAS REVIEWED AND THERE IS NO EVIDENCE OF MALFUNCTION FROM THE MANUFACTURING OF THIS WHEELCHAIR. DUE TO THE ALLEGATION AND REPORTING OF SERIOUS INJURIES THAT REQUIRED MEDICAL TRANSPORT TO THE HOSPITAL, THIS MDR IS BEING FILED. THIS INVESTIGATION WILL CONTINUE AS MORE INFORMATION IS NEEDED TO DETERMINE THE OVERALL STATE OF THE END USER'S INJURIES. THIS INVESTIGATION WILL ALSO CONTINUE AS MORE DETAILS ON THE MAINTENANCE OF THE WHEELCHAIR BECOME AVAILABLE. IF NO ADDITIONAL INFORMATION IS DISCOVERED, THIS WILL BE THE FINAL REPORT FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    THE DEALER REPORTED THE END USER STATED THE LEFT SIDE OF THE CASTER PLATE HARDWARE / LOWER BOLT BROKE DURING USAGE IN THE HOME. THIS REPORTEDLY CAUSED THE CHAIR TO PIVOT AND THE END USER TO FALL OUT OF CHAIR WHICH THEN REPORTEDLY CAUSED TWO FRACTURES TO PELVIC AND A BROKEN SHOULDER. THE END USER IS CURRENTLY IN (B)(6) HOSPITAL. THE END USER WAS CURRENTLY STILL ADMITTED AS OF THE DATE OF THE INITIAL REPORT, (B)(6) 2025. IT IS REPORTED THAT THE WHEELCHAIR IS CURRENTLY NOT IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903265 QUICKIE QXI MANUAL WHEELCHAIR IOR SUNRISE MEDICAL (US) LLC QUICKIEQXI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization