BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2862548 · Received December 10, 2012

    Report

    Report Number
    1525712-2012-02766
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL FDX-MCG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY ONE YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1163181 REV. D (FEB-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 IS A (B)(6); HOWEVER, HIS HEIGHT IS UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(6). IT WAS REPORTED BY THE CONSUMER THAT ON (B)(6) 2012 THE FDX-MCG POWER WHEELCHAIR FELL DOWN TO THE RIGHT TUMBLING SIDEWAYS DOWN THE HILL, AND AS A RESULT, ALLEGEDLY THE USER WAS INJURED. IT WAS OBSERVED THAT THE LOWER PARTS OF THE CHAIR WAS DAMAGED, AND THE UNIT RELEASED THE ELECTRONIC BRAKES WITHOUT COMMAND, LURCHED FORWARD FOR ABOUT 1-2 SECONDS, AND THEN RETURNED TO IDLE MODE. THERE IS NO ADDITIONAL INFORMATION ABOUT THIS EVENT, AND SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 Other