BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE Q7

    MDR report key: 3657740 · Received November 15, 2013

    Report

    Report Number
    2937137-2013-00058
    Event Type
    Malfunction
    Date Received
    November 15, 2013
    Date of Event
    October 28, 2013
    Report Date
    October 28, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    A MALFUNCTION INVOLVING A QUICKIE Q7 WAS REPORTED TO SUNRISE MEDICAL ON (B)(4) 2013. IT WAS REPORTED TO SUNRISE MEDICAL THAT THE END USER WAS GOING UP A RAMP WHEN BOTH OF THE ANTI TIPS ALLEGEDLY SNAPPED CAUSING THE END USER TO FALL BACKWARD. THE END USER DIDN'T SUSTAIN INJURY NOR WAS MEDIAL ATTENTION NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594516 QUICKIE Q7 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC. EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR