FDA issues early alert on GE HealthCare’s infant resuscitation system issue

GE HealthCare stated that the air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems can loosen, which can affect the delivered oxygen concentration. If this occurs, the system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

As of May 20, GE HealthCare has not reported any serious injuries or deaths associated with this issue.

Device use
The Integrated Resuscitation and Standalone Infant Resuscitation Systems provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures during manual ventilation to the infant. U.S. Food and Drug Administration