BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3013795 · Received March 20, 2013

    Report

    Report Number
    3004493922-2013-00638
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    INVACARE SUZHOU
    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 CHAIR PULLS EXTREMELY TO THE RIGHT AND IS UNCORRECTABLE WITH MOTOR BALANCE. THIS EVENT COULD CAUSE PRODUCT INSTABILITY AND POSSIBLY STRAND THE USER OR POTENTIALLY PUT THEM AT RISK FOR INJURY FROM ERRATIC OR UNINTENDED MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115433 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41

    Patients

    Seq Age Sex Outcome Treatment
    1 Other