BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE QM710

    MDR report key: 3216840 · Received July 2, 2013

    Report

    Report Number
    2937137-2013-00019
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    ITI
    PMA / PMN Number
    K083249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PER SUNRISE SALES REPRESENTATIVE (B)(6), REPORTED TO SUNRISE MEDICAL THAT THE END USER FELL OUT OF THE POWER CHAIR WHEN THE CHAIR WENT IN TO TILT MODE. (B)(6) SAID THAT THE DEALER ALLEGES THAT THE KNOBS THAT HOLD THE SEAT FRAME ON TO THE BASE FRAME WERE MISSING. THE SEVERITY OF INJURY TO THE END USER IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300575 QUICKIE QM710 WHEELCHAIR, POWERED ITI SUNRISE MEDICAL (US) LLC. EIPW11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R