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| The Oxylog 3000 Plus ventilator (upper right, orange)--Courtesy of Dräger |
Telford, PA's Dräger Medical warned customers that the alarm on more than 400 of its ventilators may inadvertently go off and cause the device to stop functioning. Dräger said that personal injury was not reported in any of those situations.
But the FDA still deemed the corrective action a Class I recall, which is reserved for situations in which "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
Dräger wrote in a letter warning customers of the problem that "our investigations showed that the error message is caused by increased electrical contact resistance of the controllers (adjustment potentiometers). The increased resistance is the result of an oxide layer on the controllers, which accumulates over a Ionger period of time. This oxide layer can only accumulate if the controllers are moved rarely or never. Our product monitoring has shown that some users rarely use the Fi02 controller or do not use it at all."
"As a preventive measure, we therefore highly recommend to move all controllers once when the device is switched off; at least 10 times to the left and right stop (minimum and maximum value). This measure suffices to clean the resistance taper of the controllers sufficiently. ln particular with the error 'Device malfunction - Poti unplugged', this method can also be used to put the device back into operation," the letter continues.
The 402 affected Oxylog 3000 and Oxylog 3000 Plus ventilators are distributed throughout the U.S., the FDA said. They were distributed between April 2007 and December 2015. On its product website, Dräger says the 3000 Plus model is used to ventilate patients during transport, and touted features like CO2 monitoring and automatic compensation for high altitudes (such as those experienced in a helicopter).
Last year Dräger was hit with three Class I recalls in 2015, on top of two in 2014.
"When the 'battery low' and 'battery depleted' alarms sound, the devices do not indicate how much time is left before the ventilator will shut down due to lack of power. Analysis by Dräger indicates that the battery should last approximately 30 minutes. If the power is lost, the 30-minute battery back-up should last until the ventilator is connected to a main power supply. If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death," the FDA warned last year when the company's Evita Infinity V500 and Babylog VN500 ventilators were recalled.
- read the letter to customers (PDF)
- here's more in the FDA's recall database | more