BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2307574 · Received October 26, 2011

    Report

    Report Number
    1525712-2011-00635
    Event Type
    Malfunction
    Date Received
    October 26, 2011
    Date of Event
    September 29, 2011
    Report Date
    October 25, 2011
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA HAS NOT BEEN INITIATED FOR THIS ISSUE. MODEL TDSP-CG (B)(4) IS APPROXIMATELY 3 YEARS OF AGE. THE USER MANUAL PART NUMBER 1143190 WAS ISSUED WITH THIS DEVICE. 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) ISSUED MFG REPORT #1525712-2011-00635. PRODUCT WAS RETURNED FOR AN EVALUATION. MOTOR WAS VERIFIED AS LEAKING GREASE. THE RISK ASSOCIATED WITH FAILURES OF THIS TYPE WAS EVALUATED UNDER (B)(4). THE RISK WAS DETERMINED TO BE AT AN ACCEPTABLE LEVEL. THIS INCIDENT DOES NOT IMPACT THAT ASSESSMENT. THIS MALFUNCTION IS CONSIDERED A RELIABILITY ISSUE THAT IS NOT LIKELY TO CAUSE HARM TO THE USER AND HAS BEEN ADDRESSED BY ENGINEERING. QUALITY REPORTS FOR CORRECTIVE ACTIONS HAVE BEEN PUT IN PLACE AND ARE EFFECTIVE IN ELIMINATING THE LEAKING GREASE CONDITION. RMA HAS NOT BEEN INITIATED FOR THIS ISSUE. MODEL TDSP-CG SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 3 YEARS OF AGE. THE USER MANUAL PART NUMBER 1143190 WAS ISSUED WITH THIS DEVICE. 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

    BACK CANES ARE ALLEGEDLY BENT. LEFT MOTOR GEARBOX IS ALLEGEDLY MAKING A NOISE. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    BACK CANES ARE ALLEGEDLY BENT. LEFT MOTOR GEARBOX IS ALLEGEDLY MAKING A NOISE. NO INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other