BEUDAMED
    FDA Adverse Event Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2583982 · Received May 22, 2012

    Report

    Report Number
    1525712-2012-00615
    Date Received
    May 22, 2012
    Date of Event
    July 25, 2010
    Report Date
    May 21, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDX3, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 6 YEAR 1 MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1114809 REV K (APR-07) 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 MALE CONSUMER'S AGE, HEIGHT, AND WEIGHT ARE UNKNOWN. THE CONSUMER HAS MUSCULAR DYSTROPHY, HIS STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. SERIOUS INJURY ALLEGED. NO MALFUNCTION ALLEGED. LETTER RECEIVED WITH A LAWSUIT ATTACHED: CUSTOMER WAS USING A GASOLINE POWERED BACKPACK BLOWER WHILE SEATED IN A POWER WHEELCHAIR. THE GASOLINE POWERED BLOWER REPORTEDLY LEAKED GASOLINE AND ALLEGEDLY CAUGHT FIRE. AT THIS TIME THERE IS NO CLAIM AGAINST INVACARE OR INDICATION OF MALFUNCTION OF PRODUCT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WARNING PER PAGE 31 IN THE OWNER'S MANUAL (B)(4) REV K (APR-07) STATES: AVOID STORING OR USING THE WHEELCHAIR NEAR OPEN FLAME OR COMBUSTIBLE PRODUCTS. SERIOUS INJURY OR DAMAGE TO PROPERTY MAY RESULT.

    Description of Event or Problem · 1

    LETTER RECEIVED WITH A LAWSUIT ATTACHED: CUSTOMER WAS USING A GASOLINE POWERED BACKPACK BLOWER WHILE SEATED IN A POWER WHEELCHAIR. THE GASOLINE POWERED BLOWER REPORTEDLY LEAKED GASOLINE AND ALLEGEDLY CAUGHT FIRE. SERIOUS INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDX3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other