Some CareFusion EnVe Ventilators are being recalled by the manufacturer because the device has a defect that can interrupt ventilation to the patient and lead to serious neurological injury or death. This recall is classified as a Class 1, which is the most serious type of recall issued by the Food and Drug Administration (FDA) and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

CareFusion EnVe Ventilators are portable ventilators used to provide breathing assistance to pediatric and adult patients in hospital and medical transport situations. CareFusion has identified potential defects with the EnVe Ventilator model 19250-001, manufactured between December 2010 and May 2011, that can interrupt ventilation to the patient.

The issues include a potential delay in resuming ventilation after reconnection, a potential automatic reset, and a potential for disconnection during transport. Failure to adequately ventilate may lead to hypoxia (reduction of oxygen supply) or hypercarbia (too much oxygen supply), which may result in serious neurological injury or death.

The manufacturer sent letters to customers by certified mail with identified potential risks and recommended steps for users to take if they encounter specific ventilator behavior described in the letter. The letter also informed customers that CareFusion would be contacting customers to coordinate a field corrective action to update the hardware and software on affected ventilators.

Any health issues or quality problems associated with the ventilators should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report/htm.

Source: FDA