BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2841036 · Received November 20, 2012

    Report

    Report Number
    1525712-2012-02248
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    November 17, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL FDX-MCG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 7 MONTHS 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. A CALL WAS PLACED TO THE REPORTER OF THIS INCIDENT, HOWEVER WOULD NOT PROVIDE ANY FURTHER INFORMATION ON THE END USER. THE MALFUNCTION HAS NOT BEEN CONFIRMED. ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DEALER STATES, JOYSTICK WON'T HOLD THE CALIBRATION. NO REPORT OF INJURY.

    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 Other