BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE QM710

    MDR report key: 3322447 · Received August 27, 2013

    Report

    Report Number
    2937137-2013-00035
    Event Type
    Injury
    Date Received
    August 27, 2013
    Date of Event
    July 20, 2013
    Report Date
    August 1, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    PMA / PMN Number
    K083249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUNRISE SALES REP (B)(4) MET WITH THE END USER AT PATIENTS CHOICE TO OBSERVE THE CHAIR INVOLVED IN THIS INCIDENT. (B)(4) NOR THE DEALER COULD DUPLICATE WHAT THE END USER DESCRIBED HAD HAPPENED WITH THE JOYSTICK. THE END USER'S POWER CHAIR IS BEING RETURNED TO SUNRISE MEDICAL FOR A MORE THOROUGH INVESTIGATION. 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

    IT WAS REPORTED TO SUNRISE MEDICAL THAT ON (B)(6) 2013 THE END USER WAS ALLEGEDLY INJURED IN HIS POWERED WHEELCHAIR. THE DEALER REPORTED THAT THE END USER IS ALLEGING THAT THE JOYSTICK BEGAN TO FLASH LIGHTS AND MAKE BEEPING SOUNDS. THE END USER ALLEGES THAT DURING THIS OCCURRENCE WITH THE JOYSTICK THE CHAIR SUDDENLY AND UNCONTROLLABLY MADE A HARD RIGHT HAND TURN OFF OF THE SIDEWALK CAUSING THE END USER TO FLIP OVER IN HIS CHAIR AND LAND ON TO THE STREET. THE END USER ALLEGES THAT THE POWER CHAIR LANDED ON TOP OF HIM CAUSING BRUISES AND INJURY TO HIS KNEE. THE END USER IS ALSO ALLEGING THAT HE IS EXPERIENCING HEADACHES SINCE THE FALL. THE END USER VISITED THE HOSP ON (B)(6) 2013 DUE TO THESE HEADACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420552 QUICKIE QM710 WHEELCHAIR, POWERED ITI SUNRISE MEDICAL (US) LLC EIPW11

    Patients

    Seq Age Sex Outcome Treatment
    1