BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2771336 · Received October 4, 2012

    Report

    Report Number
    1525712-2012-01716
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    July 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MODEL 3GTQ3-CG, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 2 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143151, REV.I(MAY-11), WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. ADDITIONAL INFORMATION WAS RECEIVED, HOWEVER, IN SPEAKING WITH THE DEALER IN THIS EVENT NO DETAIL WAS PROVIDED ON THE MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE MALFUNCTION IS NOT CONFIRMED.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE HAS REPORTED AN EVENT OF WHERE THE TILT ACTUATOR HAS GONE BAD IN LESS THAN TWO MONTHS. REPORTEDLY, THE END USER HEARD A BUZZING SOUND AND NOTIFIED THE DEALER WHO UPON SERVICING IDENTIFIED THAT THE PART NEEDS REPLACEMENT. THERE IS NO INJURY OR ILL EFFECT TO THIS END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQ3-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 64 Other