BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2437421 · Received February 3, 2012

    Report

    Report Number
    1525712-2012-00220
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Report Date
    June 2, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQ3-MCG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 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. (B)(4) 12 -(B)(4) - RESULTS OF INSPECTION: VISUAL: THE JOYSTICK'S HOUSING HAD EVIDENCE OF SCRATCHES. FUNCTIONAL: THE JOYSTICK WSA CONNECTED TO A KNOWN GOOD CONTROLLER, SET OF MOTORS, AND BATTERIES, AND THEN OPERATED FOR ONE HALF HOUR. CONCLUSION: JOY STICK WORKS FINE, COULD NOT DUPLICATE COMPLAINT.

    Description of Event or Problem · 1

    DEALER SAID THE USER CALLED AND ALLEGES THAT THE CHAIR DRIVES BY ITSELF, ONLY OUTSIDE. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    DEALER SAID THE USER CALLED AND ALLEGES THAT THE CHAIR DRIVES BY ITSELF, ONLY OUTSIDE. NO INJURY ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other