GE Healthcare has alerted health providers to inspect the bedside panels and latch areas of all Giraffe and Panda i-Res infant warmers after receiving 338 complaints of panels malfunctioning. According to news reports, in two cases, infants fell from the warmers and cracked their skulls. However, there have been no reports of fatalities, the U.S. Food and Drug Administration (FDA) states. The FDA has designated this recall as “Class I,” which is its most serious level. The recall involves all Giraffe and Panda i-Res infant warmers made between 2007 and early this year, with a total 25,204 warmers affected in the United States.
Why These Warmers Can Be Dangerous
GE said in a statement that they immediately began working with hospitals to address the issue after receiving reports of the injuries. The problem with the panels and latches appears to be related to the design. The infant warmers have front or rear maneuvering handles, but healthcare workers sometimes were instead grabbing on the panels to move the warmers. This caused cracks or breaks in the latch areas, the FDA said.
If the latch on one of the warmer panels is cracked or broken, it could disengage or fall open when an infant is placed in it. This means that an infant would not have any protection from rolling out of the warmer and falling. GE Healthcare sent out an Urgent Medical Device Correction notification letter to customers in March and an updated notification in June.
GE is also urging health providers to inspect all warmers for cracked or broken panels or latches, and to stop using them if there are any problems. Providers can continue to use the warmers if the panels and latches are operating properly. However, they must add newly provided safety labels to the panel warning about the proper and improper methods to move the warmers. This is not the first time these brands of infant warmers have been the subjects of a serious FDA recall. In 2014, the FDA issued a Class I recall involving components that were installed backward during assembly.
Product Liability Issues
It appears that a design defect is at the heart of this recall. In cases where injuries are caused as a result of manufacturing defects, design flaws or a failure to warn consumers about the dangers posed by the products, manufacturers can be held financially responsible for the victims’ losses. An experienced product defect attorney will be able to evaluate the circumstances and help victims and their families secure maximum compensation for their damages and losses.