The Food and Drug Administration (FDA) is warning consumers not to use OxySure Portable Emergency Oxygen System, Model 615.
The devices, which are used in businesses, schools and other public places, could malfunction and explode, the FDA said. It has received multiple reports of insufficient oxygen flow, burns, bruising and chemical exposure related to the devices.
The FDA is warning against using the OxySure Portable Emergency Oxygen System, Model 615. Photo courtesy of the FDA.
Trouble with the oxygen system has been ongoing. In December 2014, the FDA issued a warning letter to OxySure Therapeutics, Inc. directing the company to address the devices’ low oxygen flow rates. In June 2015, the company voluntarily recalled replacement cartridges for the system and directed consumers to discard the product. Later that year, it again failed to meet minimum FDA flow rates of 6 liters per minute for 15 minutes. The FDA also deemed the recall ineffective since some customers still were using the devices.
“Due to the adverse event reports to the FDA and the company’s failure to address the device’s safety issues noted during inspections and in the FDA’s warning letter, the FDA is concerned that patients and other users of OxySure Portable Emergency Oxygen System, Model 615 are at risk for serious adverse health consequences, such as burns and death,” the agency said in its warning.
Consumers should stop using the affected oxygen system immediately. They can find an alternative device at http://1.usa.gov/1MTK1cU by searching product code CAW.
Anyone experiencing problems with the system can file a report through the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Health care personnel should follow their facility’s reporting procedures.
