BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2387870 · Received December 23, 2011

    Report

    Report Number
    1525712-2011-01119
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Report Date
    March 29, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL PR ISSUED MFG. REPORT #1525712-201-01119. COMPONENT, RIGHT MOTOR, MODEL #(B)(4), SERIAL #(B)(4), DATE CODE (B)(4) AND LEFT MOTOR, MODEL #1141687, SERIAL #(B)(4), DATE CODE (B)(4) WAS RETURNED FOR AN EVALUATION. THE MOTOR WAS VERIFIED AS LEAKING GREASE. THE RISK ASSOCIATED WITH FAILURES OF THIS TYPE WAS EVALUATED UNDER RISK ANALYSIS 1. 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. DEVICE COMPLAINT HISTORY WAS REVIEWED. NO SERIOUS INJURY COMPLAINTS HAVE BEEN RECORDED FROM LEAKING GREASE. NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 9 MONTHS OLD. THE USER MANUAL PART NUMBER 1143190 REV K (MAR-11) 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 IS A MALE WHOSE 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 TDXSP SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 9 MONTHS OLD. THE USER MANUAL PART NUMBER (B)(4) 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 CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMER IS A MALE WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    PER (B)(6), DEALER, THE MOTORS LEAKED GREASE ON THE TILE FLOORING INSIDE THE CONSUMERS' HOME. MOTORS ARE MAKING A TERRIBLE NOISE. INFORMATION MAY BE INCOMPLETE DUE TO (B)(6) STATING THE (B)(4) AND DID NOT WANT TO COMPROMISE THE LAW. CALL WAS TRANSFERRED TO PARTS FOR A WARRANTY QUOTE. (B)(4).

    Description of Event or Problem · 1

    PER (B)(6), DEALER, THE MOTORS LEAKED GREASE ON THE TILE FLOORING INSIDE THE CONSUMER'S HOME. MOTORS ARE MAKING A TERRIBLE NOISE. INFORMATION MAY BE INCOMPLETE DUE TO (B)(6) STATING THE HIPPA LAWS AND DID NOT WANT TO COMPROMISE THE LAW. CALL WAS TRANSFERRED TO PARTS FOR A WARRANTY QUOTE. (B)(4)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other