BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJESTIC, DEFENDER

    MDR report key: 1224183 · Received November 6, 2008

    Report

    Report Number
    MW5008902
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 6, 2008
    Manufacturer
    HEALTH MOR, HMI
    Product Code
    FRF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WE PURCHASED A FILTER QUEEN VACUUM AND THREE DEFENDER AIR FILTERS FOR OUR HOME. WE ARE A FAMILY OF FIVE WITH THREE CHILDREN. MY WIFE AND I ALONG WITH ONE OF OUR CHILDREN SUFFER FROM ALLERGIES. MY WIFE AND SON TAKE PRESCRIPTION ALLEGRA WHILE I TAKE OTC MEDS TO CONTROL. WE FELT THE SYSTEM WOULD HELP WITH OUR INDOOR AIR QUALITY BUT HAVE NOTICED NO DIFFERENCE. EQUIPMENT IS REGISTERED AS A CLASS II MEDICAL DEVICE WITH THE FDA. THE VACUUM IS TOO BULKY AND HEAVY TO USE WHILE THE FILTERS ARE LARGE AND NOISY. OUR CHILDREN COMPLAINED OFTEN ABOUT THE NOISE. MY WIFE HAS AGGRAVATED A SHOULDER MUSCLE WHILE USING THE VAC AND IS NOW IN PHYSICAL THERAPY. THE DISTRIBUTOR CLAIMS THAT WE SUFFER FROM BUYER'S REMORSE RATHER THAN ACCEPT THAT THE EQUIPMENT JUST ISN'T WORKING AS PROMISED. IT MAY WORK IN OTHER HOMES BUT NOT OURS. CURRENTLY ATTEMPTING TO RETURN TO THE COMPANY. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: HOPING TO REDUCE INDOOR ALLERGENS AND IMPROVE AIR QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAJESTIC, DEFENDER VACUUM CLEANER, AIR FILTER FRF HEALTH MOR, HMI 28080058
    2 MAJESTIC, DEFENDER VACUUM CLEANER, AIR FILTER FRF HEALTH MOR, HMI 0109906

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR