BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2655965 · Received July 16, 2012

    Report

    Report Number
    1525712-2012-00958
    Event Type
    Malfunction
    Date Received
    July 16, 2012
    Report Date
    July 13, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQ-MCG, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 2 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1143151, 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. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    DEALER ALLEGES " THE CONSUMER STATED THE CHAIR WAS SLUGGISH AND IT WOULD OVERHEAT. THE DEALER BROUGHT BACK THE CHAIR AND NOTICED THE MOTORS WERE DRAGGING. THE DRAGGING ALLEGEDLY CAUSED THE CHAIR TO OVERHEAT AND SMOKE." RMA #(B)(4). NO INJURY ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 Other