BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2428307 · Received January 26, 2012

    Report

    Report Number
    1031452-2012-00008
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Report Date
    April 12, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA 859792163-R HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5PO2, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS 6 MONTHS OLD. THE USER MANUAL PART NUMBER 1143482 REV D (APR-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.

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #1031452-202-00008. THE DEVICE, CONCENTRATOR, MODEL #IRC5PO2, SERIAL # (B)(4) WAS RETURNED FOR AN EVALUATION. PRODUCT WAS APPROXIMATELY 2 1/2 YEARS OLD AT THE TIME OF THE INCIDENT. MAINTENANCE HISTORY IS UNKNOWN. THE UNIT WAS VERY DIRTY. THE ACCESS DOOR AND THE HEPA FILTER WERE NOT INSTALLED. THE PLASTIC WAS MIS SHAPEN. THE TUBING WAS CONTAMINATED WITH A BROWN TOBACCO LIKE SUBSTANCE. THE CONCENTRATOR WAS FUNCTIONALLY TESTED BUT THE UNIT WOULD SHUT DOWN. THE MOST LIKELY CAUSE WAS THE SEVERE CONTAMINATION IN THE TUBING AND THROUGHOUT THE SYSTEM. INCIDENT IS MOST LIKELY DUE TO USER ABUSE AND A LACK OF MAINTENANCE. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5PO2, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS 6 MONTHS OLD. THE USER MANUAL PART NUMBER 1143482 REV D (APR-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

    THE UNIT IS ALLEGEDLY ALARMING AND FILTER ALLEGEDLY LOOKED BURNT AND STARTED TO MELT. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    THE UNIT IS ALLEGEDLY ALARMING AND FILTER ALLEGEDLY LOOKED BURNT AND STARTED TO MELT. 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