AIR PURIFIER XL-15 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-13 for AIR PURIFIER XL-15 * manufactured by Alpine Industries.

Event Text Entries

[47076] Rptr was told the air purifier, ozone generator would help with their respiratory rpoblem. In fact, that was their sales pitch. Rptr was given a four day trial, using the device which can produce up to 312mg/hr of ozone. Rptr ran this device on 2/17, for 14 hrs, in a small space, with poor air circulation. Rptr could smell the ozone, but was told by the salesperson, tht ozone was harmless. Rptr has scleroderma, which has affected their lungs and heart. Rptr has very poor blood circulation to their hands. After telling the sales person about their medical condition, the rptr was told that this device would solve their problem, as it had done for so many other people with all sorts of respiratory problems. After breathing this air for 14 hrs, pt's breathing became labored just sitting down. Rptr had chest pains, a terrible headache, and the back of their neck was hurting, and their left little finger and ring finger became numb. Rptr's eyes felt like they were going to "pop out of my head". Rptr "had never felt quite like this before and asked myself, what did i do that was different? " rptr decided it was the purifier and decided to turn it off. Rptr was feeling better the next morning, and decided to operate the device again, not being sure about the association. Rptr experienced the same results. Rptr told the salesperson about what happened and was told that this was a normal reaction to breathing cleaner air, without particulates, and that other people have had similar complaints. Rptr said she would become acclimated to this ozone if they used the deivce for a week or more, and that it was not dangerous. There were no warnings on this device, rptr was not given an operating leaflet, or any special instructions. Rptr could not get the salesperson to concur with anything. Rptr feels their lungs were damaged, and that the blood supply to their left arm was depleted to the extent that he suffered some nerve damage. Reporter feels "this device was fraudulently represented, it is a hazardous device, and one should not be breathing the ozone that is emitted from this device. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1010944
• MDR Report Key: 75954
• Date Received: 1997-03-13
• Date of Report: 1997-03-05
• Date of Event: 1997-02-17
• Date Added to Maude: 1997-03-17
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AIR PURIFIER XL-15
• Generic Name: ION AND OZONE GENERATOR
• Product Code: FRF
• Date Received: 1997-03-13
• Returned To Mfg: 1997-02-21
• Model Number: XL-15
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 75708
• Manufacturer: ALPINE INDUSTRIES
• Manufacturer Address: 3100 84TH LANE NE BLAINE MN 55434 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention; 3. Deathisabilit	1997-03-13