BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKI Q7

    MDR report key: 3371355 · Received August 26, 2013

    Report

    Report Number
    2937137-2013-00032
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Date of Event
    July 29, 2013
    Report Date
    July 29, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE WHEELCHAIR INVOLVED IN THIS INCIDENT OWNED BY AN END USER IN (B)(6). BECAUSE OF THIS, THE PARTS THAT ARE ALLEGED TO HAVE MALFUNCTIONED WILL NOT BE RETURNED TO SUNRISE MEDICAL (US) LLC. IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE NOT BEING RETURNED TO SUNRISE (US) LLC. WE WILL MAKE 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 FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SUNRISE MEDICAL ON (B)(6) 2013, THAT THE FOLDING BACKREST BRACKETS ON A Q7 BROKE. THE DEALER REPORTED THAT THE END USER WAS IN HIS KITCHEN WHEN HE FELT THE BACKREST GIVE. THE END USER REPORTED NO FALL OR INJURY TO THE DEALER. THIS WAS REPORTED TO SUNRISE MEDICAL (US) LLC BY OUR AFFILIATE IN CASTEL HILLS, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416406 QUICKI Q7 WHEELCHARI, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1