BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE QXI

    MDR report key: 6917972 · Received October 5, 2017

    Report

    Report Number
    9616084-2017-00007
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 5, 2017
    Manufacturer
    SUNRISE MEDICAL PRIVADA MISIONES
    Product Code
    IOR
    PMA / PMN Number
    K072153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL HAS INVESTIGATED THIS ISSUE. SUNRISE QUALITY INSPECTOR HAS INSPECTED ALL OF THE LIKE ITEMS IN STOCK SINCE WE HAVE NOT RECEIVED THE ALLEGED FAILED PRODUCT FROM THE END USER. OUT OF THE 52 PIECES IN STOCK IT IS CONFIRMED THAT NO ISSUES HAVE BEEN FOUND. THE SUPPLIER ALSO CAME TO THE SUNRISE FACILITY TO CONFIRM HOW THE ASSEMBLY WORKS AND TO TROUBLE SHOOT THE PRODUCT AS WELL. ACCORDING TO THAT INSPECTION, IT WAS ALSO CONFIRMED THAT THE ITEMS PERFORMED TO SPECIFICATION WITH NO FAILURES. REPLACEMENT REAR WHEELS WERE SHIPPED TO THE DEALER ON 9/6/2017, HOWEVER, WE ARE YET TO RECEIVE THE ORIGINAL PARTS. IT IS UNKNOWN WHAT THE ROOT CAUSE OF THIS ALLEGED FAILURE IS SINCE BEARINGS SIMPLY DO NOT JUST FALL OUT OF THE WHEEL ASSEMBLY WITHOUT SOME TYPE OF PHYSICAL DAMAGE DONE TO THE WHEELS OR AXELS. IF AND WHEN THESE PARTS ARE RECEIVED FROM THE DEALER, A FULL EVALUATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE FILED WITH ANY RELEVANT FINDINGS.

    Description of Event or Problem · 1

    PER END USER, WHEEL BEARINGS ARE FALLING OUT ON BOTH SIDES OF THE CHAIR. ABOUT A WEEK AFTER THE CHAIR WAS UTILIZED THIS STARTED TO HAPPEN. USER FELL OUT OF CHAIR THREE TIMES. ONE TIME ON EACH WHEEL. SCRAPED UP ARM A LITTLE WHEN USER FELL OUT OF CHAIR. USER WAS MOVING IN THE CHAIR WHEN THE BEARING FELL OUT OF THE WHEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698844 QUICKIE QXI MANUAL WHEELCHAIR IOR SUNRISE MEDICAL PRIVADA MISIONES EIF6

    Patients

    Seq Age Sex Outcome Treatment
    1