BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3950150 · Received July 22, 2014

    Report

    Report Number
    1525712-2014-03890
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 17, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER ALLEGES DUE TO THE PROBLEM WITH THE RECALL OF THE CHAIR HAVING UNINTENDED ACCELERATION, THE CHAIR HAS RAN INTO WALLS AND DAMAGED THE ARM PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428630 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other