BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 1901358 · Received November 10, 2010

    Report

    Report Number
    1525712-2010-00166
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 17, 2010
    Report Date
    November 10, 2010
    Manufacturer
    INVACARE
    Product Code
    ITI
    Removal / Correction Number
    Z-0930-2009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER WAS TRANSGRESSING OUTSIDE AND DROVE OVER AN OUTDOOR THRESHOLD FROM WHAT IS DESCRIBED AS A FLAT TO A GRADE. THIS TRANSITION CAUSED THE CHAIR TO TIP WITH THE USER IN THE CHAIR RESULTING IN AN ALLEGED SERIOUS INJURY. AREA TRANSGRESSED AND THE STEEPNESS OF THE ALLEGED GRADE IS UNKNOWN. THIS COMPLAINT APPEARS TO BE THE RESULT OF A MALFUNCTIONING STABILITY LOCK. IF THE STABILITY LOCK FEATURE DOES NOT ENGAGE PROPERLY THE CHAIR MAY TIP. INVACARE HAS INITIATED A VOLUNTARY FIELD ACTION (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER DROVE OVER A SIDEWALK THRESHOLD WHEN THE LEFT REAR CASTER ALLEGEDLY LOCKED DOWN, HOLDING THE LEFT DRIVE WHEEL ABOVE THE PAVEMENT. THIS ALLEGEDLY CAUSED THE CHAIR TO TURN SHARPLY TO THE LEFT, FLIPPING THE CHAIR OVER. THE CONSUMER ALLEGEDLY SUSTAINED A FRACTURED RIGHT SCAPULA AND BROKEN COLLAR BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TDX5-PS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR