BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE Q7

    MDR report key: 3602154 · Received November 26, 2013

    Report

    Report Number
    2937137-2013-00065
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Date of Event
    November 12, 2013
    Report Date
    November 12, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THE IMPACT, THERE WAS SOME DAMAGE TO THE FRAME OF THE WHEELCHAIR. SUNRISE MEDICAL SENT OUT A REPLACEMENT WHEELCHAIR UNDER WARRANTY TO (B)(6) ON (B)(4) 2013. (B)(6) WILL DELIVER THE NEW WHEELCHAIR TO THE END USER. IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE BEING RETURNED TO SUNRISE MEDICAL (US) LLC. IF AND WHEN THE CHAIR/PARTS ARE RECEIVED, OUR INTERNAL FAILURE INVESTIGATOR WILL COMPLETE THE INVESTIGATION AND A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A MALFUNCTION INVOLVING A QUICKIE Q7 WAS REPORTED TO SUNRISE MEDICAL ON (B)(4) 2013. IT IS ALLEGED THAT THE END USER WAS ATTEMPTING TO LIFT THE FRONT OF HIS CHAIR TO CLEAR A CURB WHEN THE RIGHT CASTER ASSEMBLY BROKE OFF. THERE WERE NO REPORTS OF ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616307 QUICKIE Q7 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR