BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2760216 · Received September 26, 2012

    Report

    Report Number
    1525712-2012-01602
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 25, 2012
    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

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GRX-CG, SERIAL NUMBER/DATE CODE (B)(4)APPROXIMATELY 10 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143151 REV. I (MAY-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 MALE CONSUMER'S AGE IS (B)(6). 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. MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES THAT WHEN THE QUAD LINK IS MOVED OUTWARD THE JOYSTICK TURNS OFF. DEALER STATES THAT WHEN YOU BRING THE QUAD LINK INWARD THE JOYSTICK COMES BACK ON. DEALER STATES SEEMS TO BE ISSUE WITH HE JOYSTICK CABLE. MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 Other