BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 1081659 · Received July 23, 2008

    Report

    Report Number
    1056601-2008-00019
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    February 23, 2008
    Report Date
    July 22, 2008
    Manufacturer
    HOVEROUND CORPORATION
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATOR ERROR SUSPECTED - THE END USER REPORTED THAT HER HAND SLIPPED OFF THE JOYSTICK CONTROLLER, INCREASING THE UNIT'S SPEED, WHICH ALLOWED AN OBJECT TO BECOME ENTANGLED AROUND THE JOYSTICK. NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. THE OWNER'S MANUAL WARNS, "ALWAYS SET THE JOYSTICK/CONTROLLER SPEED/RESPONSE CONTROL TO BE CONSISTENT WITH THE SURROUNDING ENVIRONMENT", AND "DO NOT HANG OBJECTS FROM THE JOYSTICK".

    Description of Event or Problem · 1

    END USER REPORTED WHILE OPERATING THE MOTORIZED WHEELCHAIR IN HER BEDROOM, HER HAND SLIPPED OFF THE JOYSTICK CONTROLLER ALLEGEDLY CAUSING THE SPEED TO INCREASE. ALLEGEDLY, AT SOME POINT DURING THE INCIDENT, THE BED SHEETS BECOME ENTANGLED WITH THE CLIENT AND THE JOYSTICK CONTROLLER ALLEGEDLY CAUSING THE END USER TO DRIVE INTO THE BED FRAME AND INJURED HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOVEROUND CORPORATION MOTORIZED WHEELCHAIR ITI HOVEROUND CORPORATION MPV4

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R