The Food and Drug Administration issued a Class I recall for GE Healthcare Giraffe Infant Warmers and Panda i-Res Infant Warmers due to the latches breaking and posing a serious injury hazard to an infant occupant.
The Food and Drug Administration reported there have been 338 complaints related to the panels and latches of the bedside warmer. There have been no deaths reported, but there have been two infants who fell and fractured their skulls.
The problem is the bedside panels and latch areas can break or crack if the unit is moved using the bedside panels instead of the front and rear maneuvering handles. The panel can disengage and open, no longer protecting the infant from falling. (See diagram below)
The warmers have a front and rear handle to move the device. However, healthcare workers were accidentally grabbing onto the panel itself to move the device. This was leading to cracks or breaks in the latch area.
There have been 25,204 of the devices recalled from the consumer market. They were manufactured and distributed anywhere between October 1, 2007 and February 28, 2019.
Giraffe Infant Warmers and Panda i-Res Infant Warmers
Lot Numbers: All lots are involved.
Model Numbers: 2063568-001-XXXXXX, 2063570-001-XXXXXX, M1112198-XXXXXX, M1118179-XXXXXX .
Manufacturing Dates: October 1, 2007 to February 28, 2019.
Distribution Dates: October 1, 2007 to February 28, 2019.
Date Initiated by Firm: March 15, 2019
Infant warmers are used to provide infrared heat to infants that are unable to maintain proper body temperature on their own. These devices are typically only used in hospital settings, such as labor and delivery areas or neonatal intensive care units (NICUs).
On March 15, 2019, GE Healthcare (GEHC) sent an Urgent Medical Device Correction notification to consumers. Later on June 14, 2019, the company posted a press release along with an updated letter outlining safety actions for customers to take action:
- Inspect the bedside panels of the warmers, including the latch areas and the areas connecting the panel to the bed, for any cracks or damages. If any portion of the bedside panels or latches are cracked or broken, stop using the warmer. If the warmer bedside panels have no cracks or damage, you may continue to use the warmer.
- Apply the newly provided Safety Labels to the bedside panels of each warmer. These Safety Labels include:
- Labels that warn users of the incorrect and the correct ways to move the warmer.
- Labels that warn users to make sure the bedside panels are latched and secure.
- Provide instructional posters to staff so that they can be posted. The posters include pictures of broken and unbroken latches showing how to check the bedside panels for any damage.
- Review the Addendum to the Warmer Operation and Maintenance Manual sent with the June 14, 2019 notification letter.
The instructional labels mentioned in the release will be posted on the device itself, indicating both correct and incorrect ways to move the warmer.
Previous Complications with the Giraffe and Panda Warmers
In 2014, the FDA issued a Class I designation for the same warmers due to components that were installed backwards on the device. This involved errors delivering inaccurate levels of oxygen that could lead to injury or even death. Those devices were manufactured between April 2007 and October 2013.
Prior to that, the devices were subjected to another Class 1 recall of upgrade kits for the warmers due to mislabeling. This, again, could lead to inaccurate oxygen levels.
GE issued a warning in April 2013 for certain Giraffe and OmniBeds because the machines contained an error that could cause the machine not to revert to previous settings when switched on or off.
Do you have an infant warmer lawsuit?
The last thing any parent or caregiver wants to experience is their infant being injured or harmed by a device meant to keep them safe. If you or a loved one has a child that was injured from one of these recalled bedside warmers, you should speak with the lawyers at Johnson // Becker. You may be entitled to financial compensation by filing a lawsuit against the manufacturer.
There is absolutely no charge and no-obligation in picking up the phone to talk with us. You can reach our lawyers by calling us at (800) 279-6386, or by filling out the contact form below.