BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2512211 · Received April 2, 2012

    Report

    Report Number
    1525712-2012-00383
    Event Type
    Malfunction
    Date Received
    April 2, 2012
    Report Date
    March 30, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M94, (B)(4) IS APPROXIMATELY 1 YEAR 5 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1122145 REV I (OCT-08) 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 CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. DEALER HAS THE POWER CHAIR AND HAS SMELLED THE SMOKE. THE CHAIR ALLEGEDLY GOES IN CIRCLES ALSO. A QUOTE HAS BEEN ISSUED FOR A LEFT MOTOR.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE CHAIR HAS BEEN SMOKING AND IS GOING IN CIRCLES. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M94

    Patients

    Seq Age Sex Outcome Treatment
    1 Other