BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2912098 · Received January 11, 2013

    Report

    Report Number
    1525712-2013-00280
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Report Date
    January 11, 2013
    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) - RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQ3-CG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY FOUR YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1143155 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'S AGE, HEIGHT AND WEIGHT ARE 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)(4). THE DEALER REPORTED THAT THE 3GTQ3-CG POWER WHEELCHAIR WAS SURGING AND SLOWING DOWN WITHOUT COMMAND. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18714 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQ3-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other