BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2427061 · Received January 25, 2012

    Report

    Report Number
    1525712-2012-00154
    Event Type
    Malfunction
    Date Received
    January 25, 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

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL FDX-MCG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR 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.

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL FDX-MCG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR 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. (B)(4) - RESULTS OF INSPECTION: VISUAL: THE ELEVATE ACTUATOR'S HOUSING AND SEAT MOUNTING PLATE HAD EVIDENCE OF SCRATCHES. FUNCTIONAL: THE ELEVATE ACTUATOR WAS CONNECTED TO A 24VDC POWER SOURCE AND THEN OPERATED. THE ACTUATOR WOULD NOT OPERATE. COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    DEALER ALLEGES THE CHAIR MAKES A LOUD SQUEALING NOISE THEN DROPS ABOUT A QUARTER INCH. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    DEALER ALLEGES THE CHAIR MAKES A LOUD SQUEALING NOISE THEN DROPS ABOUT A QUARTER INCH. 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-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other