BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE XTENDER

    MDR report key: 10875428 · Received November 20, 2020

    Report

    Report Number
    1937137-2020-00016
    Event Type
    Injury
    Date Received
    November 20, 2020
    Date of Event
    July 27, 2020
    Report Date
    November 20, 2020
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    KNN
    PMA / PMN Number
    K001491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BACKGROUND INFORMATION: THE QUICKIE XTENDER PRODUCT CONSISTS OF TWO QUICK-RELEASE WHEELS, A POWER SWITCH, A BATTERY PACK, AND A CHARGING UNIT. INFORMATION FROM QUICKIE XTENDER OWNER MANUAL, MK-100156, REV B: PAGE 4 "THE QUICKIE XTENDER IS DESIGNED TO FIT ON A VARIETY OF QUICKIE WHEELCHAIRS. EACH CHAIR HAS A DIFFERENT AXLE PLATE SYSTEM THAT IS DESIGNED TO ACCEPT THE QUICKIE XTENDER QUICK-RELEASE WHEELS." PAGE 8: "Q. QUICK-RELEASE AXLES: WARNING! 1. DO NOT USE THIS CHAIR UNLESS YOU ARE SURE THAT BOTH QUICK-RELEASE REAR AXLES ARE LOCKED. 2. AN AXLE IS NOT LOCKED UNTIL THE QUICK-RELEASE BUTTON POPS OUT FULLY. 3. AN UNLOCKED AXLE MAY COME OFF DURING USE, RESULTING IN A FALL, TIPOVER OR LOSS OF CONTROL AND CAUSE SEVERE INJURY TO THE RIDER OR OTHERS. · QUICK-RELEASE AXLES SHOULD BE PERIODICALLY CLEANED AND INSPECTED FOR FUNCTION AND SIGNS OF WEAR OR BENDING. REPLACE AS NECESSARY. IF YOU FAIL TO HEED THESE WARNINGS DAMAGE TO YOUR CHAIR, A FALL, TIP-OVER OR LOSS OF CONTROL MAY OCCUR AND CAUSE SEVERE INJURY TO THE RIDER OR OTHERS." MANUFACTURER'S INVESTIGATION: ON 18-NOV-2020, THE DEALER (DISTRIBUTOR) OF THE QUICKIE® XTENDER VISITED THE END USER'S HOME TO EXAMINE THE QUICKIE® XTENDER PRODUCT. AT THAT TIME, THE TECHNICIAN CLAIMS THAT THE WHEELS WERE UNABLE TO BE REMOVED FROM THE DEVICE (WITHOUT ENGAGING THE QUICK RELEASE HANDLES) THAT INDICATES THEY WERE WELL CONNECTED TO THE AXEL OF THE WHEELCHAIR (QUICKIE 2 LITE). IT IS KNOWN (AS DOCUMENTED IN PAGE 8 OF THE QUICKIE XTENDER OWNER MANUAL ABOVE), THAT QUICK-RELEASE WHEELS MUST BE FULLY CONNECTED TO THE WHEELCHAIR AXEL TO PREVENT WHEELS FROM FALLING OFF. THIS IS A RESIDUAL RISK FROM A REQUIRED QUICK-RELEASE ASSEMBLY FOR WHEELS. CONCLUSION: IT IS PRESUMED, AT THIS TIME, THAT THE USER DID NOT FULLY LATCH THE QUICKIE XTENDER WHEEL(S) ONTO THE QUICKIE 2 LITE AXEL AND WHEN USING THE CHAIR, ONE OF THE WHEELS DETACHED AND THE USER FELL. IT IS UNKNOWN WHAT MECHANISM LED TO A BROKEN FOOT AND THERE IS NO MEDICAL CONFIRMATION OF THE CLAIM OF A BROKEN FOOT. IN ADDITION, NO MEDICAL TREATMENT WAS DESCRIBED AND, THEREFORE, THE CLAIM OF A BROKEN FOOT IS SUSPECT. THIS MDR IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION AND AN AMENDMENT WILL BE FILED SHOULD ADDITIONAL INFORMATION BE PROVIDED IN THE FUTURE. SUNRISE MEDICAL CONSIDERS THIS CLAIM UNSUBSTANTIATED AND NO FURTHER INVESTIGATION WILL BE PERFORMED AS IT IS MOST LIKELY A RESIDUAL RISK ATTRIBUTED TO USER ERROR.

    Description of Event or Problem · 1

    ON OR ABOUT (B)(6) 2020, THE END USER WAS USING HIS WHEELCHAIR, EQUIPPED WITH THE QUICKIE® XTENDER PRODUCT AND CLAIMS THAT ONE OF THE WHEELS CAME OFF RESULTING IN A BROKEN FOOT. NO INFORMATION WAS PROVIDED ABOUT WHAT THE END USER WAS DOING AT THE TIME OF THE INCIDENT AND NO INFORMATION WAS PROVIDED ABOUT WHAT MEDICAL DIAGNOSIS OR TREATMENT, IF ANY, WAS PROVIDED BY ANY MEDICAL PRACTITIONER. THE CLAIM WAS NOT REPORTED TO SUNRISE MEDICAL UNTIL 21-OCT-2020 AND, THEREFORE, IT IS FELT THAT THE CLAIM OF A "BROKEN FOOT" IS A LAY INTERPRETATION AND NOT A MEDICAL DIAGNOSIS. THEREFORE, THE CLAIM FOR A "BROKEN FOOT" CANNOT BE SUBSTANTIATED BY MEDICAL DIAGNOSIS OR TREATMENT AND IS SUSPECT. THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION, BUT IS FELT TO NOT ACTUALLY FIT THE DEFINITION OF A SERIOUS INJURY DUE TO THE SUSPECT NATURE OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344431 QUICKIE XTENDER POWER-ASSIST WHEELCHAIR DEVICE KNN SUNRISE MEDICAL (US) LLC EIXT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other