Class I FDA Recall of GE Healthcare Infant Incubators
The U.S. Food and Drug Administration (FDA) is identifying an incubator recall as a Class I, the most serious type of recall. According to the FDA recall notice, certain GE Healthcare incubators are being recalled due to a defective bedside panel. There are reports of infants falling out of the incubator and suffering injuries including brain damage. There are more than 22,000 incubators in the recall. Here is what we know so far.
FDA Recall of GE Healthcare Incubators
According to the FDA recall notice, GE Healthcare is recalling several models of infant incubator because the bedside panel does not securely latch. The panel and portholes may appear to be closed, but they are not secure. If an infant rolls into contact with the panel, it can open, creating the possibility that the infant could fall out. This is especially concerning since many incubators have a canopy covering them, which hides the panel from plain view.
The recall includes the Giraffe and Giraffe OmniBed incubators and Carestations. Hospitals rely on incubators to provide a temperature-controlled environment for infants who cannot maintain their body temperature. The side panels and portholes allow healthcare providers access to the infant without completely disturbing the temperature inside the incubator.
The devices in this recall were manufactured between April 2008 to September 2019. The FDA recall includes a total of 22,961 devices across the United States. So far, the FDA has confirmed six reports of infants falling out of the incubators. No infants have died, but all six who fell suffered injuries including skull fractures, edema and hematomas.
Not the First Giraffe Recall
In July 2019, GE Healthcare recalled Giraffe and Panda i-Res infant warmers due to a similar defect in the side panel. At the time, the FDA reported more than 300 complaints about the devices. Only two injuries had been reported at the time. In this previous recall, officials blamed poor design for the defects. The incubators have handles so that staff can move them around as needed. However, medical staff often grab the incubators by the panels in order to move them. The manufacturer notes that using the panels for movement could cause the latches to break.
What to Do About the FDA Recall of Giraffe Incubators
In November 2019, GE Healthcare sent a letter to healthcare providers using the devices. The letter contains updated instructions for using the incubators and properly securing the latch. The instructions include:
- Upon closing the latch, pull on the panel to make sure the latch is secure and the red tab is not visible.
- Pull on the portholes to verify the latch is secure after closing the door.
- Attach safety labels (supplied by the manufacturer) to every device affected by the recall.
- Review the user manual and keep a copy with the incubator.
- Use provided posters – “Giraffe Incubator/OmniBed Risk of Patient Fall” – in prominent locations where healthcare staff can see them.
- Confirm that all healthcare providers and staff using the incubators are aware of the manual, recall and updated instructions.
- Confirm that all staff members understand the new instructions and risk of infants falling from the incubators.
- Label spare panels with appropriate instructions and warnings, even if they are not installed.
- Complete and return the form provided which documents hospital staff training for incubator and OmniBed use.
Healthcare providers and facilities with questions or concerns should contact GE Healthcare directly. Complaints can also be made through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
What Can Parents Do About Infant Injury?
Medical devices like infant incubators have a purpose to help infants maintain their body temperature. Infants who rely on an incubator are often premature or have health problems that require specialty care. For a parent, it is unimaginable that a device designed to help your child could be dangerous to them. There is no doubt that the parents whose infants fell and are suffering head and brain injuries are devastated.
As a consumer, you trust that devices and products are safe, especially those used in hospitals. A defect can cause you to lose faith in the manufacturing and inspection processes that we count on as consumers and parents. If you are concerned about an infant injury, you should know that you have legal rights.
If your child has an injury due to a GE Healthcare incubator or OmniBed, contact Birth Injury Guide. Let our birth injury lawyer help you understand your legal rights and the options you may have to recover compensation. Manufacturers should absolutely be accountable when their products are defective. Even more so, they should be accountable for injuries that their devices cause.
Learn more about defective products and your rights by calling Birth Injury Guide at 1-877-415-6603. You can also request more information via our online form.