BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2598244 · Received June 5, 2012

    Report

    Report Number
    1525712-2012-00686
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Report Date
    June 1, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSI-HD, (B)(4) IS APPROXIMATELY 2 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1154294 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 IS A (B)(6) MALE, (B)(6). 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. THE DEALER STATED THAT THERE WAS AN ERROR CODE, E501, FOR THE RIGHT MOTOR AND BRAKE. THE MOTOR ALLEGEDLY LOCKED UP MAKING THE CHAIR TURN ON THE SIDEWALK. THE RIGHT MOTOR HAS BEEN REPLACED ON THE POWER CHAIR. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED RECEIVING AN ERROR CODE E501 ON THE RIGHT MOTOR AND BRAKE - MOTOR LOCKED UP MAKING THE CHAIR TURN ON THE SIDEWALK. NO INJURY ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 Other