BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3163467 · Received June 11, 2013

    Report

    Report Number
    1525712-2013-04554
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A TDXSI POWER CHAIR VEERING TO THE LEFT. THIS EVENT CAN CAUSE THE DEVICE TO HAVE UNINTENDED MOVEMENT AND INJURY MAY OCCUR TO THE USER OR BYSTANDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264720 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other