BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2973290 · Received February 21, 2013

    Report

    Report Number
    1525712-2013-01352
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    February 21, 2013
    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

    CONSUMER STATES THE FOOTBOARD AND ARM PADS ARE LOOSE. CONSUMER ALSO STATES THAT THE UNIT WILL START TO TILT WHEN HE PICKS UP HIS SPEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75801 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M41

    Patients

    Seq Age Sex Outcome Treatment
    1 Other