BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2647476 · Received July 10, 2012

    Report

    Report Number
    1031452-2012-00110
    Event Type
    Malfunction
    Date Received
    July 10, 2012
    Report Date
    July 9, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5P, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 4 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1143482 REV A (FEB-07) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S 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 FEMALE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. CONSUMER ALLEGED THAT THE CONCENTRATOR HAS MOLD ON THE FILTER AND THAT SHE HAS HAD A HARD TIME GETTING A FILTER SENT TO HER FROM THE DEALER. NOT SURE AS TO WHAT FILTER SHE IS REFERRING TOO. ON PAGE 23 OF THE MANUAL PART NO 1143482 IT STATES THE FOLLOWING: CAUTION: DO NOT OPERATE THE CONCENTRATOR WITHOUT THE FILTER INSTALLED. NOTE: FOR THIS PROCEDURE, REFER TO FIGURE 6.1 ON PAGE 24. NOTE: THERE IS ONE CABINET FILTER LOCATED ON THE BACK OF THE CABINET. REMOVE THE FILTER AND CLEAN AT LEAST ONCE A WEEK DEPENDING ON ENVIRONMENTAL CONDITIONS. NOTE: ENVIRONMENTAL CONDITIONS THAT MAY REQUIRE MORE FREQUENT CLEANING OF THE FILTERS INCLUDE, BUT ARE NOT LIMITED TO: HIGH DUST, AIR POLLUTANTS, ETC.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT THE CONCENTRATOR HAS MOLD ON THE FILTER. SHE IS HAVING A HARD TIME GETTING ONE FROM DEALER. 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 IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other