BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2342755 · Received November 18, 2011

    Report

    Report Number
    1525712-2011-00907
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Report Date
    March 19, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #1525712-2011-00907. THE COMPONENT, MOTOR MODEL #163476, SERIAL # (B)(4) AND DATE CODE (B)(4) WAS RETURNED FOR AN EVALUATION. CHAIR WAS APPROXIMATELY 1 YEAR OLD AT THE TIME OF THE INCIDENT. THE MOTOR WAS FUNCTIONALLY TESTED AND NO DISCREPANCIES WERE FOUND. THE MOTOR DID SHOW EVIDENCE OF LEAKING GREASE. LEAKING GREASE IS CONSIDERED A RELIABILITY ISSUE THAT IS NOT LIKELY TO CAUSE HARM TO THE USER. NO SERIOUS INJURY COMPLAINTS HAVE BEEN RECORDED FROM LEAKING GREASE. THIS COMPLAINT FOR THE MOTORS LOCKING UP COULD NOT BE DUPLICATED. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL M51, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR OLD. THE USER MANUAL PART NUMBER 1125085 REV J (OCT-08) 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

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL M51, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 1 YEAR OLD. THE USER MANUAL PART NUMBER 1125085 (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 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 LEFT MOTOR ALLEGEDLY LOCKED UP CAUSING THE CONSUMER TO ALMOST RUN INTO A WALL. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE LEFT MOTOR ALLEGEDLY LOCKED UP CAUSING THE CONSUMER TO ALMOST RUN INTO A WALL. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51

    Patients

    Seq Age Sex Outcome Treatment
    1 Other