FDA Announces Action after More than 300 Complaints
The U.S. Food and Drug Administration (FDA) has disclosed that multinational conglomerate General Electric (GE) must immediately recall around 25,000 units of its Panda i-Res and Giraffe Infant Warmers, in response to nearly 350 complaints from consumers, including two involving infants who suffered skull fractures. Thus far, no children have died because of defects associated with the products.
The infant warmers are used to provide additional heat for infants who have difficulty maintaining their own body temperatures. Most of the devices are used exclusively in hospital settings, such as neo-natal intensive care units. The warmers are designed with a flat surface on the top and panels on the sides to keep the infant from rolling out. The flat surface is integrated into the whole unit and cannot be moved or set in place separately.
According to reports, the unit weighs more than 200 pounds and is extremely difficult to move. It has handles specifically designed to help move the unit, but, in a number of situations, hospital workers have used the bedside panels (rather than the handles) to move the unit, causing damage to the latches that hold the panels shut. The injuries have been suffered when compromised latches malfunctioned and infants rolled out of the warmer onto the floor.
GE first started manufacturing the warmers in 2007. In 2019, GE sent an urgent notice to all hospitals, warning of the potential danger. GE has also indicated that it will be issuing new and improved “instructions for use” to all customers.
GE may have potential liability under a legal theory of product liability. In a product liability claim, any party within the chain of distribution may be responsible for injuries sustained as a result of dangerous and defective design, dangerous and defective manufacture or negligent marketing of a product.
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