The CareFusion 203, EnVe, and ReVel ventilators were recalled because of the potential for damage to their power cord adaptors that can cause loss of power and complete shut off. The ventilators were manufactured from May 2009 to August 2014.
The CareFusion 203, EnVe and ReVel ventilators are used on patients who require respiratory support or mechanical ventilation and weigh a minimum of 11 pounds (5 kg). They are used in hospitals, during transport of a patient, and at home to provide constant or intermittent respiratory support.
The EnVe and ReVel ventilators can be operated using either batteries or external power sources (AC or auto lighters). The manufacturer, CareFusion 203, Inc. of Minneapolis, Minnesota, recalled these devices because they found that the pins of the external power connector did not always align properly with the input port of the ventilator. This misalignment can damage the pins on the connector and possibly short circuit the ventilator. A short circuit in the power supply may prevent the ventilator battery from recharging, and the ventilator could lose power unexpectedly. Ventilator shut-off from power failures may lead to serious patient injury or death. The company has received 256 reports of the incident with no reported injuries or deaths.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
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