BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2654192 · Received July 13, 2012

    Report

    Report Number
    1525712-2012-00926
    Event Type
    Malfunction
    Date Received
    July 13, 2012
    Report Date
    July 10, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP-CG, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143190 REV K (MAR-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 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. TERRITORIAL BUSINESS MANAGER (TBM) CALLED STATING THAT THE RIGHT SIDE ELEVATING LEG RESTS (ELR) ON THE TDXSP-CG POWER CHAIR ALLEGEDLY LOCK UP. THE LEFT ELR OCCASIONALLY LOCK UP. DEALER ALSO STATED THAT THE ACTUATOR IS MAKING NOISE. (B)(4) HAS BEEN ISSUED FOR THE REPLACEMENT ELR'S AND THE DAMAGED PRODUCT IS TO BE RETURNED TO INVACARE FOR AN INSPECTION. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    "PER TBM ELR LEG ISSUE. NO PHYSICAL DAMAGE BUT RIGHT SIDE LOCKS UP AND ACTUATOR NOISE AND THE LEFT SIDE OCCASIONALLY LOCKS UP." (B)(4). NO ALLEGED INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other