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Leading global medical device company, CareFusion, is recalling its AVEA Ventilator because of a defect that could cause it to stop ventilating, which if left undetected could be deadly for patients. This is the second Class 1 recall of a CareFusion ventilator. The company recalled lots of its EnVe Ventilators for a defect that affected ventilation. A Class 1 recall 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.
The AVEA Ventilator recall was initiated because the device can develop a failure where the ventilator activates a false Extended High Peak alarm, opens the safety valve and stops ventilating. CareFusion has received 94 reports of incidents in which the AVEA Ventilator has apparently malfunctioned. No deaths or injuries were reported.
The EnVe Ventilators were recalled because of a potential delay in resuming ventilator connection; a potential automatic reset; and a potential for disconnection upon transport.
Failure to adequately ventilate may head to hypoxia or hypercarbia, which may result in serious neurological injury or death.
CareFusion has notified customers of the ventilator recalls and provided steps in which to take to remedy the problems. Any problems experienced following use of these devices should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
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