BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3110154 · Received May 13, 2013

    Report

    Report Number
    1525712-2013-03755
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Report Date
    April 17, 2013
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE RIGHT MOTOR GEARBOX ON AN M51 POWER CHAIR PULLING. THIS CREATES THE POTENTIAL FOR ERRATIC/UNINTENDED MOVEMENT AND INJURY TO THE USER OR BYSTANDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210265 POWERED WHEELCHAIR 890.3860 ITI INVACARE M51

    Patients

    Seq Age Sex Outcome Treatment
    1 Other