BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3000719 · Received March 12, 2013

    Report

    Report Number
    1525712-2013-01921
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 14, 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

    THE DEALER REPORTED THAT THE HARDWARE FOR THE LATERALS ON THE CHAIR ARE DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED. THIS MAY COMPROMISE THE STABILITY OF THE USER'S UPPER TORSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103975 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG-GT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other