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The Food and Drug Administration (FDA) issued a safety communication recommending against the use of OxySure Portable Emergency Oxygen System, Model 615.
OxySure Portable Emergency Oxygen System does not require a prescription and is intended to produce oxygen for emergency use. Since June 2013, at least 1,000 units of the Oxygen System have been distributed nationwide.
The FDA determined that a voluntary recall of OxySure replacement cartridges for Model 615, in June 201, was ineffective. Consumers, businesses, schools, and healthcare providers are now recommended to stop using the Oxygen System due to several device malfunctions, including ineffective oxygen delivery and chemical reactions in the canisters that could cause them to explode. Consumers are to immediately transition to an alternative FDA-cleared emergency oxygen device.
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The FDA’s recommendation is based on multiple complaints and reports of adverse events associated with use of this device, which include insufficient oxygen flow, re-breathing of exhaled gases, burns, bruising (contusions) and chemical exposure. An inspection in September 2014 detected the device’s oxygen flow rate to be too low and did not meet the FDA-cleared minimum specification (6L/min for at least 15 minutes). The company was then served a warning letter for deficiencies in oxygen flow rate problems.
During a follow-up inspection after the June 2015 voluntary recall, the device’s oxygen flow rate failed to meet the FDA-cleared minimum specification again. A recall audit check also found that the voluntary recall was ineffective because the affected products were still available for use by customers. The FDA served the company a letter requesting they identify corrective actions to ensure that the defective product was not being used by consumers.
Due to the company’s failure to address the safety issues identified during inspections and in the FDA’s warning letter, the FDA stated its concerns over the user’s risk for serious adverse health consequences (eg, burns, death).
For more information call (800) 638-2041 or visit FDA.gov.
