BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2832641 · Received November 14, 2012

    Report

    Report Number
    1525712-2012-02120
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    November 7, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSIV-HD, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 4 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1154294 REV. H (JUN-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. THE FEMALE CONSUMER'S AGE IS (B)(6), AND WEIGHT IS UNKNOWN. 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. MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. THE DEALER STATES THAT THE JOYSTICK ON THE CHAIR SPEEDS UP AND SLOWS DOWN ON ITS' OWN. A WARRANTY QUOTE FOR A REPLACEMENT JOYSTICK WAS COMPLETED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSIV-HD

    Patients

    Seq Age Sex Outcome Treatment
    1 62 Other