BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2429888 · Received January 27, 2012

    Report

    Report Number
    3004493922-2012-00028
    Event Type
    Malfunction
    Date Received
    January 27, 2012
    Report Date
    March 29, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG. REPORT #3004493922-2012-00028. COMPONENT, JOYSTICK MODEL #117291, SERIAL #(B)(4) WAS RETURNED FOR AN EVALUATION. PRODUCT WAS APPROXIMATELY 1 YEAR OLD AT TIME OF INCIDENT. THE JOYSTICK HAD IMPACT DAMAGE. THE JOYSTICK ALSO HAD A FOREIGN SUBSTANCE ON AND INSIDE IT. THIS CONTAMINATION (E.G. LIQUID OR OTHER CONDUCTIVE MATERIAL) COULD CAUSE UNPREDICTABLE COMMANDS FROM THE JOYSTICK. THIS CONDITION MIGHT BE RESOLVED BY THE DRYING OUT OF THE COMPONENTS OVER TIME. THE JOYSTICK WAS FUNCTIONALLY TESTED AND NO DISCREPANCIES WERE OBSERVED. MANUFACTURER VIEWS THIS INCIDENT AS ABUSE/LACK OF MAINTENANCE. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41SRR, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR 2 MONTHS OLD. THE USER MANUAL PART NUMBER 1143206 REV G (FEB-09) 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

    RMA 859782360 HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41SRR, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR 2 MONTHS OLD. THE USER MANUAL PART NUMBER 1143206 REV G (FEB-09) 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 CONSUMERS 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

    THE CHAIR IS ALLEGEDLY MAKING A SQUEAKING NOISE AND ALLEGEDLY SPEEDS UP SUDDENLY. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CHAIR IS ALLEGEDLY MAKING A SQUEAKING NOISE AND ALLEGEDLY SPEEDS UP SUDDENLY. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other