Malfunction risk forces GE Healthcare to recall Carestation ventilators
The Food and Drug Administration (FDA) has announced a Class I recall for certain GE Healthcare Carestation anesthesia delivery systems. This recall is due to a potential risk of ineffective ventilation in Volume Control Ventilation (VCV) mode, which could lead to hypoxia and, in severe cases, death.
The recall affects 15 specific Carestation models, impacting over 14,000 individual devices. However, the exact number of models affected or their specific names have not been disclosed in the available sources.
GE Healthcare has not specified a timeline for the resolution of the issue, but they have provided advice on how to mitigate the risks associated with the recalled devices. Healthcare professionals are advised to run a ventilation screening test on the affected devices to ensure their safety.
If a device passes the test, it can be used in accordance with the instructions, but only in pressure control ventilation or pressure control ventilation volume guarantee mode for mechanical ventilation. It is crucial to avoid using VCV mode for patient ventilation.
Additional alarms will alert users to the effects of inadequate ventilation on the patient. In case of a fault, the devices' inflated bellows will stop moving, triggering audible and visual alarms.
Manual mode can be used to provide ventilation or allow spontaneous ventilation of the patient. The devices are used in patients from newborns to adults in hospitals, surgical centers, and clinics for providing monitored anesthesia care, general inhalation anesthesia, and ventilatory support.
It is worth noting that no reports of serious injury or death have been received by GE Healthcare as of yet. The FDA has labeled the recall as a Class I event, which is the severest recall classification.
GE Healthcare has not yet provided a timeline for the resolution of the issue, but they are working closely with the FDA to address the problem. Healthcare professionals are encouraged to consult the FDA's website or contact GE Healthcare for the latest information on the recall and the steps to take to ensure patient safety.
- The FDA's Class I recall includes GE Healthcare's Carestation anesthesia delivery systems due to a potential risk in the VCV mode that could lead to hypoxia or death.
- The recall involves 15 specific Carestation models, impacting over 14,000 individual devices, although the exact models have not been disclosed.
- Healthcare professionals are advised to use the devices in only the pressure control ventilation or pressure control ventilation volume guarantee mode for mechanical ventilation.
- If a device passes the ventilation screening test, it can be used as normal but avoiding VCV mode for patient ventilation.
- Additional alarms have been implemented to alert users to the effects of inadequate ventilation on the patient, with audible and visual alarms triggered if the devices' inflated bellows stop moving.
- The devices are used in various healthcare settings, such as hospitals, surgical centers, and clinics, to provide monitored anesthesia care, general inhalation anesthesia, and ventilatory support for patients from newborns to adults.
- To ensure patient safety, healthcare professionals are encouraged to consult the FDA's website or contact GE Healthcare for the latest information on the recall and the steps to take in accordance with medtech regulation and healthcare analytics.
