BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2390440 · Received December 28, 2011

    Report

    Report Number
    1031452-2011-00083
    Event Type
    Malfunction
    Date Received
    December 28, 2011
    Date of Event
    December 19, 2011
    Report Date
    April 11, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #1031452-2011-00083. THE DEVICE, CONCENTRATOR MODEL #IRC5P, SERIAL #(B)(4) HAS BEEN RETURNED FOR AN EVALUATION. THE HEPA FILTER WAS A NON INVACARE FILTER. THE UNIT WAS HOT TO THE TOUCH WHEN OPERATED WITH THE NON INVACARE FILTER. THERE WAS ALSO A METALLIC SMELL. THE HEPA FILTER WAS REPLACED WITH AN INVACARE FILTER AND THE CONCENTRATOR FUNCTIONED CORRECTLY. NO DISCREPANCIES WERE OBSERVED. INCIDENT IS LIKELY DUE TO A LACK OF CORRECT MAINTENANCE. OPERATOR'S GUIDE HAS INSTRUCTIONS ON THE PROPER AND SAFE USE OF THE PRODUCT. NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5P, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 8 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 IS A MALE WHOSE 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

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5P, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 8 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 CONSUMER IS A MALE WHOSE 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 ALLEGES THAT AFTER 45 MINUTES ON THE CONCENTRATOR, IT STARTS SMELLING AND THE CONSUMER TASTES A BURNT TASTE. NO SERIOUS INJURY ALLEGED.

    Description of Event or Problem · 1

    CONSUMER ALLEGES THAT AFTER 45 MINUTES ON THE CONCENTRATOR, IT STARTS SMELLING AND THE CONSUMER TASTES A BURNT TASTE. NO SERIOUS 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 IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other