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. News reports indicate that in two instances, the warmers caused infants to fall and fracture their skulls.
However, the U.S. Food and Drug Administration (FDA) has reported no fatalities. The FDA has designated this recall as “Class I,” 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 of 25,204 warmers affected in the United States.
Why These Warmers Can Be Dangerous
GE said they immediately began working with hospitals to address the issue after receiving reports of the injuries. The design appears to be the cause of the panel and latch problems. The FDA said that infant warmers have front or rear maneuvering handles, but healthcare workers sometimes grab the panels to move the warmers, causing cracks or breaks in the latch areas.
If a warmer panel’s latch is broken, it may open when a baby is placed inside. 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 also wants health providers to check all warmers for broken panels or latches and stop using them if there are any issues. Providers can continue using the warmers if the panels and latches operate properly.
However, they must add newly provided safety labels to the panel warning about the proper and improper methods of moving the warmers. This is not the first time these infant warmer brands have been the subject of a serious FDA recall. In 2014, the FDA issued a Class I recall involving components 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 by manufacturing defects, design flaws, or a failure to warn consumers about the dangers posed by the products, the manufacturer can be held financially responsible for the victims’ losses. An experienced Southern California product defect attorney can evaluate the circumstances and help victims and their families secure maximum compensation for their damages and losses.
Source: https://www.massdevice.com/ge-healthcare-recall-involves-tens-of-thousands-of-infant-warmers/
