BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2618893 · Received June 18, 2012

    Report

    Report Number
    1525712-2012-00747
    Event Type
    Malfunction
    Date Received
    June 18, 2012
    Report Date
    June 14, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. HOWEVER, A QUOTE FOR THE RMA HAS BEEN PROVIDED - QT (B)(4). MODEL 3GAR-CG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 8 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 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 IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE DEALER ALLEGES THAT THE POWER CHAIR WILL SLOW THEN SPEED UP INTERMITTENTLY AND ONLY WHEN DRIVING AT HIGH SPEED. THE BATTERY LOAD ALLEGEDLY TESTED OK. REPLACEMENT QUOTE HAS BEEN ISSUED AND THE PRODUCT IS BEING RETURNED TO INVACARE FOR AN INSPECTION AND EVALUATION. NO INJURY.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE CHAIR SLOWS THEN SPEEDS UP INTERMITTENTLY AND ONLY AT HIGH SPEED DRIVING. QT (B)(4). NO INJURY ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other