BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2843097 · Received November 21, 2012

    Report

    Report Number
    1525712-2012-02263
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    November 18, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQ3, SERIAL NUMBER/DATE CODE UNKNOWN IS APPROXIMATELY OF AN UNKNOWN AGE. THE OWNER'S MANUAL PART NUMBER 1081229 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. IN SPEAKING WITH THE CONSUMER, HER AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S FULL 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. THE MALFUNCTION HAS NOT BEEN CONFIRMED. IF ANY FURTHER INFORMATION OR UPDATE IS PROVIDED, THE NEW INFORMATION WILL BE SENT IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    THE END USER REPORTS THE FRONT RIGGINGS ARE NOT OPERATING PROPERLY AND THEY SWING AWAY AND SHE IS UNABLE TO MOVE THEM. ALSO OF CONCERN IS THAT THE FOOTPLATE DOES NOT STAY RAISED CAUSING HER TO FEEL UNSTABLE DURING TRANSFERS. ALSO VOICED CONCERN OF THE COMPOSITE OF THE FOOTPLATE. THE END USER REPORTS SHE HAS PARALYSIS AND LOSS OF STRENGTH WHICH IS AFFECTING HER ABILITY TO USE THIS DEVICE. THERE IS NO REPORT OF AN INJURY.

    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