BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2371344 · Received December 14, 2011

    Report

    Report Number
    1525712-2011-01060
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Date of Event
    November 15, 2011
    Report Date
    December 13, 2011
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA 859689058 HAS BEEN INITIATED FOR THIS ISSUE. MODEL R51 LXP SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 MONTHS OLD. THE USER MANUAL PART NUMBER (B)(4) WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMER IS A (B)(6). THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    DEALER STATES THAT WHILE THE CONSUMER WAS DRIVING THE CHAIR, THE LEFT DRIVE TIRE ALLEGEDLY FELL OFF, AND ALSO LOST THE KEY AND OTHER ATTACHING HARDWARE. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET R51 LXP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 Other