| Developers: | GE HealthCare |
Content |
Giraffe OmniBed neonatal resuscitation system provides full care for newborns by maintaining the required temperature in a double-walled incubator and providing easy access to the baby in open resuscitation mode.
2023: Chemicals threatening babies found in devices The manufacturer acknowledged the problem
On October 16, 2023, the U.S. Food and Drug Administration (FDA) reported that GE HealthCare neonatal incubators could release chemicals that threaten infant health. The manufacturer acknowledged the problem and suggested a way to solve it.
We are talking about GE HealthCare Giraffe OmniBed Carestation and Giraffe Incubator Carestation systems. These carefully designed solutions improve the quality of newborn nursing, creating a protected environment that provides natural treatment, baby growth and neurodevelopment. The 10.4-inch color touchscreen display helps optimize the performance of medical personnel and provides monitoring and control of the environment surrounding the infant. Protection against infections is implemented with improved functions and the ability to contactless disconnect the alarm signal. If any of the incubator panels are open, the Air Boost function can be activated to protect the child from heat loss and ensure a stable ambient temperature.
As reported in the FDA notice, these systems may exhibit increased release of formaldehyde, cyclohexanone and other volatile chemicals. This can provoke negative effects such as neurological disorders or breathing problems (including asthma, impaired lung function, inflammation or irritation).
However, over time, the level of released substances decreases rapidly. Therefore, GE HealthCare recommends that medical institutions, after installing the Giraffe OmniBed Carestation and Giraffe Incubator Carestation incubators, leave them turned on for one week in a well-ventilated room. After that, the devices will be ready for clinical use. Those devices that were shipped after September 5, 2023 initially undergo the necessary procedures, and therefore clinics can use them immediately after receipt.[1]
2019
Recall of defective incubators from which children fall
In mid-December 2019, GE Healthcare began recalling defective incubators Giraffe, Giraffe OmniBed and Carestations due to the increased risk of neonatal falls.
GE Healthcare has warned health professionals that due to a manufacturing defect, the portholes and bedside panels of Giraffe incubators cannot be securely fixed upright. If an infant comes into contact with such a panel or porthole, it may fall out of the incubator. The company has already received six reports of infant falls, resulting in a variety of injuries, including skull fractures, hematomas and swelling. No deaths have yet been reported.
Defective incubators were produced between April 2008 and September 2019. The company has already recalled 22,961 devices. However, GE Healthcare advised users that they could continue to use the Giraffe Incubator, OmniBed, Incubator Carestation and OmniBed Carestation systems by following a series of instructions. The manufacturer recommends that users attach and lock the bedside panels, as well as make sure that medical professionals know the instructions for blocking the panels and porthole doors.
The Food and Drug Administration (FDA) ranked this recall campaign as the first most serious class. This means that the use of defective devices can lead to serious injury or even death.
This is not the first time GE Healthcare has recalled Giraffe incubators. Previously defective systems were recalled from the market due to incorrect installation of components during assembly. As a result of this error, the devices inaccurately measured the oxygen concentration in the incubator, resulting in excessive or insufficient oxygen saturation of the air.[2]
Device recall due to defective heating plates
On July 12, 2019, GE Healthcare alerted healthcare professionals to possible malfunctions of Giraffe and Panda i-Res newborn panel warmers. The company received 338 complaints about defective warmers, with babies falling off panels and fracturing skulls in two cases. Data on deaths have not yet been reported.
Regulatory authorities have assigned a class I label to the problem, that is, a defect that threatens a person's life or can lead to serious injuries. All Giraffe and Panda i-Res newborn warmers were manufactured between 2007 and early 2019, and a total of 245,204 defective devices were sold in the United States.
GE Healthcare said in a statement that the company takes patient safety seriously and immediately began working with hospitals to address the issue. It turned out that the defect was associated with design flaws. Newborn warmers are equipped with front or rear handles for maneuvering, however, paramedics sometimes carry the warmers by holding onto the panels themselves, which leads to cracks in the fasteners. If the mount of one of the heater panels is broken, it ceases to perform a barrier function, so that the infant can roll up and fall to the floor.
In March 2019, GE Healthcare sent out a warning to customers about an identified malfunction, followed by a press release and an updated notification letter in June. GE Healthcare has asked health care professionals to inspect all warmers for cracks and stop using them immediately if there are any problems. In other cases, health workers are instructed to comply with the rules for moving heaters. The company also provided training posters for hospital accommodation.[3]
2016: Announcement in Russia
At the end of November 2016, GE Healthcare announced the Giraffe Omnibed neonatal resuscitation system in Russia. The novelty was presented at the IX All-Russian Educational Congress "Anesthesia and Resuscitation in Obstetrics and Neonatology" in Moscow.
Giraffe Omnibed simplifies the process of nursing newborns, creating conditions for premature babies that are as close as possible to in utero. The system allows you to track body temperature, weight and other parameters, helping doctors monitor changes in the condition of the child and quickly take action in the event of deviations in indicators.
The incubator can transform into an open resuscitation system, and in its usual state, it provides parents with full access to the baby for nursing.
 | Nursing is a complex set of measures consisting of reducing external influences (light, noise, decrease in sensory load), pain sensations, improving physiological stability, appropriate stimulation for adequate development of the brain. To solve these problems, high-tech equipment is being developed, with the help of which you can create optimal comfortable conditions for a newborn: choose a temperature, acoustic mode. Compliance with the conditions for nursing premature babies contributes to more effective adaptation to the external environment, and, as a result, to the subsequent improvement of their quality of life, - notes Irina Vinogradova, Doctor of Medical Sciences. |  |
As of 2016, about 6% of babies are born with low or very low body weight. To increase the prognosis of nursing of such newborns, innovative medical technologies and modern medical and diagnostic equipment are used.[4]
Notes
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