BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA TRAC

    MDR report key: 520416 · Received March 25, 2004

    Report

    Report Number
    MW1031687
    Event Type
    Injury
    Date Received
    March 25, 2004
    Report Date
    March 25, 2004
    Manufacturer
    TEFTEC CORP.
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TEFTEC CORP MANUFACTURES A WHEELCHAIR CALLED THE OMEGATRAC. THE WHEELCHAIR HAS BEEN DRIVING ON ITS OWN DUE TO A PROBLEM WITH THE ELECTRONICS. THIS HAS HAPPENED WITH NEUMEROUS CUSTOMERS AND HAS ALREADY RESULTED IN ONE LAW SUIT. THE MFR IS AWARE OF THE PROBLEM BUT REFUSES TO ADDRESS THE SITUATION. RPTR FEELS SOMEONE IS GOING TO GET SERIOUSLY HURT OR KILLED WITH THIS PROBLEM. THE WHEELCHAIR SIMPLY STARTS TO DRIVE ON ITS OWN WITHOUT ANYONE ASSISTING. RPTR KNOWS OF ONE CUSTOMER THAT HAD THE CHAIR ALMOST DRIVE OUT THE SIDE OF A VAN. THIS WHEELCHAIR WEIGHS IN EXCESS OF 400 LBS. THEIR SOLUTION TO THE PROBLEM HAS BEEN A TEMPORARY FIX, AND THE CHAIR RETURNS TO THE SAME BEHAVIOR OR A COMPLETE ELECTRONIC REPLACEMENT TO THE TUNE OF ABOUT $8000.00 TO THE CUSTOMER. NONE OF THE MAYBE 500 CUSTOMERS HAVE BEEN INFORMED THIS MAY BE A PROBLEM WITH THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGA TRAC ELECTRIC WHEELCHAIR ITI TEFTEC CORP. OMEGA TRAC *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R