The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ device issue with certain GE HealthCare infant resuscitation systems and warmers.
The FDA’s notice points out that, a month ago, GE HealthCare issued a letter to affected customers recommending that certain Giraffe6 and Panda brand infant resuscitation and warmer systems with blenders be removed from use or inspected prior to continued use.
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In the context of the systems which provide the basic equipment required for the pulmonary resuscitation of infants, the blender refers to a component that mixes air and oxygen to deliver a controlled oxygen concentration.
The FDA alert relates to GE HealthCare’s discovery that a component of the air-oxygen blender 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 too little or too much oxygen reaching the patient.
In an 8 May letter to customers, GE HealthCare advised customers to inspect their Giraffe6 and Panda systems and to remove units with an affected blender from use and to contact a GE HealthCare sales representative.
As of 20 May, GE HealthCare has not reported any serious injuries or deaths associated with this issue.
For devices that must be used prior to being corrected, GE HealthCare advised customers to undertake the pre-use checkout procedure steps. These steps include inspecting systems for damage and performing a multipoint oxygen concentration check as outlined in the system’s user manual.
If units fail these inspections, they should be removed from patient use. If they pass and the multipoint oxygen concentration check meets specifications, they can still be used. However, GE HealthCare caveated that oxygen concentration should be verified with an independent oxygen analyser on a ‘frequent basis’ until the unit is corrected.
This is not the first time that GE HealthCare’s Giraffe and Panda product ranges have come under scrutiny. In 2019, GE HealthCare initiated a voluntary recall of Giraffe and Panda i-Res Infant Warmers due to side panels and latches that may have been cracking and breaking open. Designated as Class 1 by the FDA, the recall affected 25,204 devices manufactured and sold in the US since 2007.
