BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3160608 · Received June 10, 2013

    Report

    Report Number
    1525712-2013-04517
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    INI
    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

    POTENTIAL FOR INJURY ASSOCIATED WITH A FAULTY THROTTLE POTENTIOMETER ON A 220 SCOOTER. THIS EVENT COULD CAUSE THE PRODUCT TO MAKE UNINTENDED AND ERRATIC MOVEMENTS AND POSSIBLY CAUSE INJURY TO THE USER OR BYSTANDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260291 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI INVACARE TAYLOR STREET 220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other