The US Food and Drug Administration (FDA) has had to recall over one thousand portable oxygen (O2) devices from OxySure Therapeutics, Inc. after several device malfunctions were revealed, including ineffective O2 delivery and chemical reactions in the canisters that could cause them to explode.
The OxySure Portable Emergency Oxygen System is intended to produce O2 for emergency use, but the FDA has received multiple complaints and reports of adverse affects associated with the use of this device, including insufficient O2 flow, re-breathing of exhaled gases, burns and exposure to chemicals.
The FDA is still concerned that users of the portable O2 instrument are at risk of serious adverse health consequences, including burns and even death
During an FDA inspection of an OxySure facility in September 2014, the company’s internal testing revealed the device’s O2 flow rate to be too low, so it did not meet the FDA-cleared minimum specification of six litres per minute for a minimum time of 15 minutes.
It is understood that since June 2013, the Texas-based medical technology company has distributed at least one thousand units of the faulty OxySure Model 615 throughout the US.
Despite several attempts at recalling the dud devices and OxySure’s continual failure to address its safety issues, the FDA is still concerned that users of the portable O2 instrument are at risk of serious adverse health consequences, including burns and even death.
In a press release, the US organisation states, “The FDA will continue to work with OxySure to bring these devices into regulatory compliance and will keep the public informed if significant new information becomes available.”
It is urging customers to stop using the 615 Model and to switch to an alternative FDA-cleared emergency O2 device immediately.