BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE Q7

    MDR report key: 3381848 · Received September 3, 2013

    Report

    Report Number
    2937137-2013-00037
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    August 5, 2013
    Report Date
    August 5, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE NOT BEING RETURNED TO SUNRISE MEDICAL (US) LLC. WE WILL HAVE EVERY EFFORT TO COMPLETE AN INVESTIGATION THROUGH EITHER OBTAINING PICTURES OR VIDEO OF THE CHAIR INVOLVED, OR BY PERFORMING AN INVESTIGATION ON A CHAIR OF EQUIVALENT CONSTRUCTION. IF AND WHEN MORE INFO CAN BE OBTAINED FROM THAT INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DEALER REPORTED THAT THE END USER HAS HAD PROBLEMS WITH HER WHEELCHAIR. THE DEALER REPORTED THAT BOTH BACK BRACKETS HAVE BROKEN AND THAT SHE HAS ALSO HAD TO HAVE BOTH OF HER CASTER HOUSING SPLINE KITS REPLACED. NO FALLS OR INJURIES HAVE RESULTED FROM THESE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435962 QUICKIE Q7 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1