FDA Alerts

Class 1 Recall: GE Healthcare, Giraffe OmniBed and Giraffe Incubator

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.

Tue Jan 08 2013By Kaylee McCaffrey

 

Reason for Recall: 
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).

 

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