BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2342720 · Received November 18, 2011

    Report

    Report Number
    1031452-2011-00053
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    June 24, 2011
    Report Date
    November 18, 2011
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5PO2V, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 MONTHS OLD. THE USER MANUAL PART NUMBER 1143482 REV E (NOV-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. (B)(4) - DEVICE EVALUATION COMPLETED. CONDITION OF RETURN: THE UNIT APPEARS TO BE USED AND IN FAIR CONDITION. RESULT ANALYSIS: VISUAL: THE CONCENTRATOR HAS 404 HOURS ON THE HOUR METER. FUNCTIONAL: THE CONCENTRATOR WAS POWERED ON AND THE FLOW SET AT 5 LPM ON THE FLOW METER. AFTER APPROXIMATELY, 1 HOUR OF OPERATION, THE YELLOW LIGHT AND THE RED LIGHT CAME ON SIMULTANEOUSLY. ALTHOUGH THE CONCENTRATOR WAS WARM, THERE WAS NO BURNING SMELL DETECTED. THE COVER WAS REMOVED FOR INSPECTION AND IT WAS DETERMINED THAT THE FAN WAS NOT WORKING. CONCLUSION: THE UNIT FAILED AS A RESULT OF A DEFECTIVE FAN.

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5PO2V, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 MONTHS OLD. THE USER MANUAL PART NUMBER 1143482 REV E (NOV-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

    CONSUMER ALLEGEDLY NOTICED A BURNING SMELL COMING FROM THE UNIT AND CALLED THE DEALER. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    CONSUMER ALLEGEDLY NOTICED A BURNING SMELL COMING FROM THE UNIT AND CALLED THE DEALER. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other