BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4132878 · Received October 1, 2014

    Report

    Report Number
    1525712-2014-06580
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 12, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    SWING ARM CRACKED WHERE IT ATTACHES TO THE HEADTUBE,PHYSICAL DAMAGE , END USER HIT SOMETHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612793 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other