BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2355434 · Received December 1, 2011

    Report

    Report Number
    1525712-2011-00996
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Report Date
    February 28, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQ3, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 4 MONTHS OLD. THE USER MANUAL PART NUMBER 1143151 (B)(4) WAS ISSUED WITH THIS DEVICE. (B)(4). IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4) - INITIAL, (B)(4) ISSUED MFG REPORT 1525712-2011-00996. THE COMPONENT, JOYSTICK, MODEL #1127291, SERIAL #(B)(4), WAS RETURNED FOR AN EVALUATION. NO EXTERNAL OR INTERNAL DAMAGE WAS OBSERVED. THE JOYSTICK WAS FUNCTIONALLY TESTED AND NO DISCREPANCIES WERE OBSERVED. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQ3, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 4 MONTHS OLD. THE USER MANUAL PART NUMBER 1143151 REV I (MAY-11) WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    ALLEGES THAT JOYSTICK IS TURNING ON BY ITSELF. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    ALLEGES THAT JOYSTICK IS TURNING ON BY ITSELF. NO INJURY ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other