BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3930197 · Received July 11, 2014

    Report

    Report Number
    1525712-2014-03620
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    August 28, 2013
    Report Date
    June 6, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    TBM WAS MADE AWARE BY THE PROVIDER OF A WORK ORDER FOR THIS CHAIR WHICH ADVISED THAT ON (B)(6) 2013, THE USER WAS STUCK IN TILT IN THE STREET NEAR WORK. PROVIDER STATES THE CHAIR IS NOT RESPONDING TO ANYTHING AND JOYSTICK IS NOT RECOGNIZING SEATING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406472 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSR-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other