The Carestation anesthesia systems are being recalled due to a risk of ineffective ventilation in volume control mode, which could lead to serious injury or death.
GE HealthCare is correcting certain Carestation devices due to the risk that they may not provide effective ventilation when used in volume control ventilation mode, according to a medical device recall notice from the US Food and Drug Administration (FDA).
In these systems, effective ventilation can be achieved in pressure control ventilation or pressure control ventilation volume guarantee modes—or with manual ventilation.
If this issue occurs, GE HealthCare notes that it will be apparent to the Carestation user through observation and multiple alarms. The inflated bellows, visible through transparent glass, will stop moving, and an audible alarm and visual “Unable to Drive Bellows” message will alert the user. Additional alarms, including apnea, EtCO2 low, MVexp low, RR low, and TVexp low, will also alert the user to inadequate ventilation.
The use of the affected product may cause serious adverse health consequences, including failure of ventilation resulting in hypoxia and death. At this time, GE HealthCare has reported no serious injuries or deaths related to this issue.
Intended use of the Carestation is to provide monitored anesthesia care, general inhalation anesthesia, and/or ventilatory support to a wide range of patients (neonatal, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics by a clinician qualified in the administration of general anesthesia.
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type.
The affected product names are Carestation 620/650/650c and 750/750c Anesthesia Systems.
Customers in the US with questions about this recall should contact GE HealthCare Service at 1-800-437-1171.
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