BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4034373 · Received August 25, 2014

    Report

    Report Number
    1525712-2014-04995
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 4, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) PATIENT WAS COMING OUTSIDE OVER THE THRESHOLD OF THE DOOR. THE CARE TAKER TURNED AROUND TO PICK THRESHOLD PIECE UP AND THE CHAIR MOVED FORWARD ON THE PORCH, ROLLED DOWN THE POURED SIDEWALK RAMP. THE FRONT TWO CASTERS AND ONE DRIVE WHEEL WENT OFF THE RAMP AND THE BOTTOM OF THE CHAIR CAUGHT ON THE CONCRETE AND THE CARE TAKER WAS ABLE TO GRAB THE CHAIR BEFORE IT TIPPED ONTO THE PATIENT. DEALER STATED THE PATIENT ALLEGEDLY CAME OUT OF THE CHAIR AND THE CARE TAKER CAUGHT HER BUT THERE WERE SCRAPES AND BRUISING FROM HER FALLING ON THE GROUND. THE EMT WERE CALLED TO CHECK HER OUT SHE HAD MINOR BRUISING AND SCRAPES ON PATIENT LEFT SIDE. NO ADDITIONAL MEDICAL ATTENTION SOUGHT. THE CHAIR MOVED ALLEGEDLY WITHOUT THE PATIENT OR CARETAKER TOUCHING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514777 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 66 Other