BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3965105 · Received July 29, 2014

    Report

    Report Number
    1525712-2014-04089
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THAT THE CONSUMER WAS DRIVING IN THE STREET AND THE UNIT STOPPED AND BEGAN TO FLASH A 4 FLASH ERROR CODE. PROVIDER STATES SOMEONE WAS ABLE TO PUSH THE USER BACK TO HIS HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440909 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSIV-HD-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other