IONIC BREEZE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-20 for IONIC BREEZE manufactured by Sharper Image Corp..

Event Text Entries

[20432958] Rptr is still in recovery after a 10-day hospitalization. Rptr feels it is imperative for the fda/public to be aware of the harm these units cause, especially for the people to whom they market, ie, people with respiratory diseases and sinus conditions. In 1999, rptr prepared to move into a new office in which internal "improvements" were taking place in the building, ie, painting, new carpeting, tiling. To help clear the odors and prevent lungs from being harmed, the person across the hall from rptr convinced them that the alpine living air unit would put ozone in the air, eliminating chemicals that might filter into rptr's individual office. Being naive and trusting the good intentions of friend, rptr accepted offer to place the unit in office. The unit was placed on "burst" when rptr was not there, per the instructions, pouring a tremendous amount of ozone into the air, and on low when rptr was working. Within the first week working in office, rptr became ill with pneumonia. Unfortunately, rptr did not associate the illness with the ozone unit and continued using it to an even greater extent. Rptr sought treatment and was put on high doses of prednisone and antibiotics. Rptr felt short of breath during the days they worked but believed the source to be something other than the ozone, although rptr could not discover it, and lungs did not clear up. Several clients complained of nausea, headaches and difficulty in breathing while in rptr's office. Rptr had been so convinced that the units were "helpful" that they still did not make the connection. Two mos later, rptr replaced the living air unit with the sharper image's ionic breeze, also an air purifier that releases ozone into the air. Condition did not improve. A month after, a living air unit was lent to rptr by a friend. Rptr put it in their child's room to help asthma. Because child did not develop symptoms as a reaction to it, nor did condition worsen (or improve), rptr believed that the unit might be helpful in purifying the air. Rptr ordered one for themself. The following month rptr went on vacation and condition finally began to improve. Early the next month rptr's unit arrived. Rptr also ordered several units for family and friends, trying to insure that condition would keep improving by keeping the air "pure". Within a week, pneumonia returned with a vengeance and rptr was so weak they could hardly move. About one week after using the unit in the room, rptr was hospitalized, severely ill, fighting for their life. Rptr's physician ran every test possible trying to discover the cause. No clear evidence of any pathogen was found. The physicians were baffled. Rptr returned home and left the unit off for a while since spouse could not tolerate the odor. Rptr's condition began to improve. Early the next month the units for rptr's child, sibling, and friend arrived. As soon as they used them, they began complaining of headaches and sore throats. At that point, as rptr's condition had started to deteriorate again while using the unit, rptr's spouse researched the alpine living air purifier on the web. Rptr's spouse read the enclosed literature with horror. The nature and severity of rptr's illness finally made sense. Rptr's spouse immediately notified child, sibling, and friend, telling them to stop using the units, along with their friends who had sold them the units. They were horrified. Rptr has no doubt now that the ozone from the units weakened their lungs, especially while having mixed with the chemicals in office, and caused chemical poisoning and severe lung and neuromuscular damage. Rptr can no longer be around chemicals at all, including such cleaning solvents as windex, cleaning powders, most perfumes, anything. Rptr's lungs react immediately and rptr feels the overwhelming weakness within mins when exposed to the fumes of the chemicals. Every day rptr struggles to regain some of the strength they once had, which included the ability to work out on a stairmaster, ride a stationary bike, jog up to three miles, play tennis, and lift weights. Rptr is now capable of walking for thirty mins at a slow pace, after almost five months of recovery. Rptr is hoping that the fda will research and hopefully be able to stop the sale and misrepresentation of these deadly "filters". Rptr feels grateful to be alive, although they are afraid they will never regain their original strength or breathing ability. "please don't let these people sell these "purifiers", harming or potentially, killing, anyone else. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002747
MDR Report Key275683
Date Received2000-04-20
Date of Report2000-04-20
Date of Event1999-05-01
Date Added to Maude2000-05-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameIONIC BREEZE
Generic NameAIR PURIFIER
Product CodeFRF
Date Received2000-04-20
Model NumberNI
Catalog NumberNI
Lot NumberNA
ID NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key266837
ManufacturerSHARPER IMAGE CORP.
Manufacturer Address650 DAVIS ST. SAN FRANCISCO CA 94111 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2000-04-20

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