Explosive Oxygen Unit Killed One Person and Injured Another

The manufacturer of the device has recalled more than 160,000 of the oxygen units.

FDA has given its most serious recall designation to a portable oxygen unit from Western/Scott Fetzer Company (Westlake, OH) after it received complaints that the device can burst into flames. In one case, a healthcare employee sat the OxyTote unit down by his side and the device exploded, killing him. In another, the unit was inadvertently dropped from 4 ft., injuring another person.

The company states that mishandling or dropping the device can spark a flash fire within the device, causing the canister to burst.

Western/Scott Fetzer Company initially recalled the device on January 31, 2015. In a letter, it stated that three (rather than the two specified in the FDA notice) of the devices had ignited, seriously injuring two people and killing another. “All three ignition events occurred in the time period from March 2014 to January 2015, and all three events occurred following the Oxygen cylinder refilling process, not during product use in a healthcare setting,” the letter stated.

The recall involved 161,674 units distributed in the United States that were sold between January 1, 2009 and September 30, 2014.

Western Enterprise’s recall notice explained that the recall was limited to its OxyTote and related products mounted on aluminum oxygen cylinders whereas those mounted to steel cylinders were exempt from the recall.

The company, in the aforementioned letter, concluded that the products “manufactured with a certain type of cylinder sealing o-ring are more prone to this rare but serious type of event.”

The recall notice was distributed to an array of entities, however, including distributors, EMS staff, ambulance service providers, and oxygen tank certification service providers.