GE Healthcare’s Giraffe and Panda i-Res Infant Warmers are designed to help newborns maintain an optimal body temperature when they can’t do so on their own. However, a Class I recall was issued for the GE Healthcare Infant Warmers in July 2019, after at least two infants were injured while the devices were in use.
Every year, between 10 to 15 percent of the infants born in the United States are admitted to the NICU (Neonatal Intensive Care Unit) for reason that include:
Premature newborns and critically ill infants often have difficulty maintaining a stable body temperature. Hospital delivery rooms typically use radiant infant warmers, such as the GE Healthcare Giraffe and Panda i-Res devices, when they require simultaneous open access and external heat.
The Giraffe and Panda i-Res Infant Warmers utilize an infrared heat sources that focuses radiant heat onto the attached infant bed. The innovative recessed heater facilitates easy access during procedures, while ensuring the baby stays warm and caregivers remains cool and comfortable. Clinicians can activate the infant warmers well in advance, so the beds are warm by the time the infant arrives.
GE Healthcare also designed both warmers to allow for:
The Giraffe Infant Warmer features GE Healthcare’s patented “Baby Susan” rotating mattress to minimize unnecessary baby stimulation, as well as integrated SPO2 and T-Piece Resuscitation Systems, so healthcare practitioners can access everything required to deliver resuscitation therapy to high-risk newborns.
The resuscitation systems are optional on the Panda i-Res Infant Warmer, which also includes an integrated in-bed scale for quick and easy infant weighing. The integrated in-bed scale is optional on the Giraffe warmer.
In July 2019, the U.S. Food& Drug Administration (FDA) announced a Class I recall for more than 25,000 GE Healthcare Giraffe and Panda i-Res Infant Warmers, after two babies fell from the warmer beds and suffered skull fractures. The Class I designation is the agency’s most serious recall category, and indicates use of the affected GE Healthcare Infant Warmers could result in serious injury or death.
According to the FDA, the bedside panels and latch areas of the Giraffe and Panda i-Res Infant Warmers can crack or break if the unit is moved using the bedside panels instead of the front or rear maneuvering handles. If a baby comes in contact with a bedside panel with a cracked or broken latch, the panel can disengage and fall open, no longer protecting the infant from falling from the warmer.
GE Healthcare has apparently received 338 complaints related to the bedside panels/latches, including the two reported skull fractures.
The GE Healthcare Infant Warmer recall includes all Giraffe and Panda i-Res Infant Warmers manufactured and distributed from October 1, 2007 to February 28, 2019. It’s important to note, however, that GE Healthcare never actually removed the products from the market. Instead, the company replaced broken parts and provided hospitals with additional safety instructions and and warning stickers.
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