BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2843273 · Received November 22, 2012

    Report

    Report Number
    1525712-2012-02325
    Event Type
    Malfunction
    Date Received
    November 22, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 22, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQ3-CG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 4 YEARS, 3 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143151 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. IN SPEAKING WITH THE REPORTER, 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. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE JOYSTICK WAS SMOKING. IN SPEAKING WITH THE REPORTER IT WAS LEARNED THAT WAS NO INJURY OR ILL EFFECT. AT THIS TIME, THE END USER IS NOT USING THIS DEVICE SINCE HE HAS RENTED AN ALTERNATIVE WHEELCHAIR. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQ3-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 39 Other