BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2414985 · Received January 13, 2012

    Report

    Report Number
    1031452-2012-00005
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Report Date
    April 12, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5PO2 SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 MONTH 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.

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #1031452-2012-00005. THE DEVICE, CONCENTRATOR, MODEL #IRC5PO2, SERIAL #(B)(4) WAS RETURNED FOR AN EVALUATION. THIS UNIT WAS NEW WHEN ALLEGEDLY IT ALARMED AND SHUT DOWN. THE CONCENTRATOR WAS FUNCTIONALLY TESTED WITH NO DISCREPANCIES WERE OBSERVED. THE UNIT DID NOT GET HOT, ALARM OR HAVE A BURNING SMELL. THE COMPLAINT COULD NOT BE DUPLICATED. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5PO2 SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 MONTH 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.

    Description of Event or Problem · 1

    UNIT WAS PLUGGED IN AT DEALER, TURNED ON AND YELLOW ALARM LIGHT ALLEGEDLY CAME ON AND CONCENTRATOR IMMEDIATELY EMITTED A BURNING ODOR AND THE UNIT SHUT OFF IMMEDIATELY. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    UNIT WAS PLUGGED IN AT DEALER, TURNED ON, AND YELLOW ALARM LIGHT ALLEGEDLY CAME ON AND CONCENTRATOR IMMEDIATELY EMITTED A BURNING ODOR AND THE UNIT SHUT OFF IMMEDIATELY. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other