inforMED
MalfunctionFRF

MAJESTIC, DEFENDER

Received Nov 6, 2008 · Event occurred Oct 1, 2008

Report MW5008902 · MDR key 1224183

Device

Generic name

Vacuum Cleaner, Air Filter

Manufacturer

Health Mor, Hmi

Model number

28080058

Product problems

  • Design/structure problem
  • Noise

Patient

39 YR

  • Injury

Narrative

Description of Event or Problem

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.