BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2567990 · Received May 10, 2012

    Report

    Report Number
    1525712-2012-00535
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Report Date
    May 9, 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. HOWEVER, A QUOTE FOR THE RMA HAS BEEN PROVIDED QT (B)(4). MODEL TDXSC2-CG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR AND 2 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1149267 REV E (JUN-10) 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 CONSUMER'S AGE, HEIGHT AND WEIGHT ARE 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.

    Description of Event or Problem · 1

    DEALER STATED THAT THE CONSUMER ALLEGEDLY TIPPED FORWARD TWICE AND FELL OUT OF CHAIR, AND THE LEFT FRONT IS ALSO ALLEGEDLY BENT FROM THE CASTER TO THE CYLINDER. QT.# (B)(4). NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSC2-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other