AUDIENCE: Risk Manager, Biomedical Engineer
ISSUE: The Giraffe Incubator and Giraffe OmniBed may randomly delete stored information and enter new information in its place (over-write) when the device turns “on” or recovers from a power failure. When this occurs, the heater or oxygen delivery option will turn “off” and the new set point will be “0”. In addition, alarms may not appropriately alert users that heater or oxygen delivery options are “off” or that the set points are less than intended. The alarm failure may go unnoticed.
All newborn babies using this device are at risk of serious adverse health consequences, including death, due to this malfunction. Inaccurate temperature can result in hypothermia (dangerously low body temperature) or hyperthermia (dangerously high body temperature), and inaccurate oxygen regulation can result in hypoxia (low blood oxygen) or hyperoxia (high blood oxygen). In addition, newborn babies requiring transport may be at increased risk of adverse health consequences due to potential malfunction when moving from one power source to another (wall outlet to/from battery power).
These products were manufactured and distributed from August 01, 2012 to December 01, 2012.
BACKGROUND: The Giraffe OmniBed can function as an incubator (closed mode) or as a warmer (open mode) and can transition from one mode to the other on the user’s demand. Incubators and warmers are used to maintain the body temperature of a newborn baby. In “closed mode”, the OmniBed provides heat through a closed, temperature-controlled environment. In “open mode”, the device provides heat in an open environment using overhead heaters.
The Giraffe Incubator is an infant incubator 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 that is used to provide stable amounts of oxygen to newborn babies.
RECOMMENDATION: On January 8, 2013, GE Healthcare sent "Urgent Medical Device Correction" letters to affected customers notifying them of the problem, the affected devices, and the action to be taken by the customer. In addition, customers were given instructions for continued 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:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[04/24/2013 - Recall Notice - FDA]