GE Healthcare's Giraffe OmniBed, Incubator Subject of a Class I RecallApr 25, 2013
GE Healthcare’s Giraffe Incubator and Giraffe OmniBed may randomly delete or overwrite stored information when the devices are switched on or recover from a power failure.
When this happens, the heater or oxygen delivery option also will turn off – which users may not be aware of because the alarm may not go off as it is supposed to.
Due to this malfunction, newborn babies using this device are at risk of extremely serious adverse health consequences, including death, the U.S. Food and Drug Administration (FDA) warns in a statement.
Inaccurate temperature can result in hypothermia (a condition that results from a dangerously low body temperature) or, the obverse, hyperthermia (a condition resulting from a dangerously high body temperature).
Inaccurate oxygen regulation can result in hypoxia (low blood oxygen) or hyperoxia (high blood oxygen). In addition, newborn babies who need to travel for any distance may be at an increased risk of adverse health consequences due to a potential malfunction when moving from one power source to another (for example, from a wall outlet to battery power).
These products were manufactured and distributed from Aug. 1, 2012, to Dec. 1, 2012.
The Giraffe OmniBed is designed to function as an incubator (when in closed mode) or as a warmer (when in open mode); it can transition from one mode to the other, on the user’s demand. Incubators and warmers maintain the body temperature of a newborn baby. In “closed mode,” the OmniBed provides heat through a closed, temperature-controlled environment, while in “open mode,” the device provides heat in an open environment using overhead heaters.
The Giraffe Incubator is used to maintain the body temperature of a newborn baby by providing heat through a closed, temperature-controlled environment. This device may include a controlled oxygen delivery system to provide stable amounts of oxygen.
On Jan. 8, 2013, GE Healthcare sent "Urgent Medical Device Correction" letters to the appropriate customers, notifying them of the problem, as well as which devices are affected, and what type of action is required of the customer.
In addition, customers were given instructions for ongoing use of the Giraffe OmniBed and Giraffe Incubators. GE Healthcare will correct all affected devices at no cost, and will contact customers to arrange for this correction.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting a report online at www.fda.gov/MedWatch/report.htm; downloading a form; or calling toll-free 1-800-332-1088.