BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2344453 · Received November 21, 2011

    Report

    Report Number
    1525712-2011-00929
    Event Type
    Malfunction
    Date Received
    November 21, 2011
    Report Date
    November 21, 2011
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL FDX SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 2 MONTHS OLD. THE USER MANUAL PART NUMBER 1163181 (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) - PRODUCT WAS RETURNED ON (B)(4) AND INSPECTED. THE DEVICE WAS EVALUATED AND THE ISSUE COULD NOT BE DUPLICATED AND NO PROBLEM WAS FOUND. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL FDX SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 MONTHS OLD. THE USER MANUAL PART NUMBER 1163181 REV. B (JUL-10) 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 CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    DEALER ALLEGES THAT WHEN THE CHAIR WAS CHARGED FOR THE FIRST TIME THERE WAS A BURNING SMELL COMING FROM THE CHARGER. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    DEALER ALLEGES THAT WHEN THE CHAIR WAS CHARGED FOR THE FIRST TIME THERE WAS A BURNING SMELL COMING FROM THE CHARGER. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET FDX FOR FORMULA CG WITH MK6I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other