BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE RHYTHM

    MDR report key: 861069 · Received May 4, 2007

    Report

    Report Number
    2937137-2007-00009
    Event Type
    Malfunction
    Date Received
    May 4, 2007
    Date of Event
    April 5, 2007
    Report Date
    May 4, 2007
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RIGHT MOTOR WAS EVALUATED BY THE QUALITY ENGINEER AND FOUND THAT THE BRAKE OF THE MOTOR DOES NOT ENGAGE. THE SALES REP DID STATE THAT THE RAMP WAS NOT TO CODE.

    Description of Event or Problem · 1

    SUNRISE SALES REP RECEIVED A CALL FROM THE DEALER WHICH STATED THAT THE END-USER WAS GOING DOWN A RAMP AT HIS HOME WHEN THEY LET GO OF THE JOYSTICK AND WHEELS CONTINUED TO ROLL, AND THE USER FELL OUT OF THE CHAIR. THERE WAS NO INJURY TO THE END-USER OF ANY KIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE RHYTHM WHEELCHAIR POWERED ITI SUNRISE MEDICAL QUICKIE RHYTHM P/N EIPW10

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other