GE Healthcare has issued a medical device correction for its Carestation anesthesia monitoring platform, according to a June 24 report from Mass Device.
If uncorrected, the error can lead to injury or death, according to the FDA’s classification.
GE has warned users of the Carestation platform not to use the “volume control ventilation mode” until the device is corrected.
When in VCV mode, certain devices may fail to provide effective ventilation, but users can still receive effective ventilation in “pressure control ventilation” or “pressure control ventilation volume guarantee” modes or with manual ventilation.
If an issue occurs with VCV mode, the device signals users through observation and multiple alarms.
Using affected systems may lead to ventilation failure, potentially resulting in hypoxia and death, according to the report, though GE HealthCare has reported no issues or deaths thus far.
Customers should perform a screening test for the affected system, and if it passes, they may continue using their device, according to the report.
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