BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3970382 · Received July 31, 2014

    Report

    Report Number
    1525712-2014-04216
    Event Type
    Malfunction
    Date Received
    July 31, 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

    IT WAS REPORTED THE UNIT IS NOISY AND HOT TO THE TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447597 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other