DALLAS — The U.S. Food and Drug Administration issued a safety alert on Tuesday, recommending that people and organizations “stop using” the OxySure Model 615 portable emergency oxygen generator.
More than 1,000 of the medical units have been distributed nationwide, the FDA said in its online alert.
“The FDA has received multiple complaints and reports of adverse events associated with use of this device including insufficient oxygen flow, re-breathing of exhaled gases, burns, bruising (contusions) and exposure to chemicals."
OxySure Therapeutics, Inc., a Frisco-based company, designed the device to save lives.
WFAA first reported on the product in 2009 after the Frisco Independent School District spent $65,000 to purchase 110 of the OxySure units.
In issuing its safety alert Tuesday, the FDA said it received word of "several device malfunctions, including ineffective oxygen delivery, and chemical reactions in the canisters that could cause them to explode."
The Model 615 is the same machine at the center of a local lawsuit by Nicole Kennedy, who argues the OxySure device failed when it was used on her five-year-old daughter, Meaghan Levy.
“I couldn’t be any happier. I just don’t want this to happen to any other mother or anyone in general; another child, another mother, another person. I’m just happy it’s going in the direction its going,” Kennedy said after learning about the FDA safety alert.
In December 2013, Meaghan swallowed a push pin at a Frisco ISD elementary campus and later died.
The coroner said the child died from asphyxiation.
But Kennedy sued OxySure, claiming Model 615 — which was used on Meaghan at the school — failed to provide the girl with oxygen, and instead put lethal chemicals into her body.
In December 2014, the FDA issued a warning letter to OxySure, saying this specific model had a problem with the flow rate of oxygen.
Six months later, in June 2015, OxySure voluntarily recalled cartridges for Model 615.
Mazin Sbaiti, an attorney for OxySure, told WFAA in a written statement Wednesday that the company disagrees with the FDA's safety alert.
“OxySure strongly disagrees with both the content and import of the FDA's March 29, 2016, safety notice about the OxySure Model 615 device. We are sure that the thousands of people saved over the years with our product also disagree. Notably, the notice cites no evidence that shows that the OxySure Model 615 device does not perform up to FDA standards, or that it fails to perform as intended — indeed, the record of usage to save lives would suggest otherwise. We continue to stand by our product, its innovativeness and the value it brings to society. FDA's sudden and unprompted notice is not only full of inaccuracies; it is plainly arbitrary and capricious.”
Two weeks ago, in a conference call for investors, Oxysure talked about a next generation Model 615, which the company said will have even more safety features.
The FDA said it will continue to work with OxySure to come into compliance.
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