BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3222773 · Received July 12, 2013

    Report

    Report Number
    1525712-2013-05665
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 21, 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

    THE PROVIDER REPORTED THE TDXSP-CG POWERED WHEELCHAIR WILL INCREASE AND/OR DECREASE IN SPEED UNEXPECTEDLY DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322613 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other