BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3260635 · Received August 1, 2013

    Report

    Report Number
    3004493922-2013-01706
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Report Date
    July 18, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES CHAIR TOOK OFF ON ITS OWN AND THREW END USER OUT OF THE CHAIR. (SEE NOTE IN INFO GATHERING TAB). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360395 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M51

    Patients

    Seq Age Sex Outcome Treatment
    1 50 Other