The Food and Drug Administration has announced two Class I recalls, the most serious type of recalls:
All lot numbers of GE Healthcare’s Giraffe Infant Warmers and Panda i-Res Infant Warmers because the bedside panels and latch areas of the warmers can crack or break if the unit is moved using the bedside panels instead of the front or rear maneuvering handle. If an infant 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.
Hamilton Medical AG Hamilton-G5 Ventilators (PN 159001) due to the potential for “Panel connection lost” error message resulting in the ventilator to stop working and enter an ambient state. When the ventilator enters an ambient state, the patient breathes room air unassisted and the ventilator sounds a high priority alarm with visual blinking LEDs alerting medical staff. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.
Use of these devices may cause serious injuries or death.
Infant radiant warmers provide infrared heat in a controlled manner to infants who are unable to maintain their body temperature on their own. Radiant heat from an infrared heat source is focused onto the bed to warm the infant. Panda i-Res warmers are typically used in hospital Labor and Delivery areas while Giraffe Infant Warmers are typically used in Neonatal Intensive Care Units (NICUs).
FDA says GE Healthcare has received a total of 338 complaints related to bedside panels/latches. This includes two infants who fell from warmers and fractured their skulls. There were no deaths reported.
On March 15, 2019, GE Healthcare sent an Urgent Medical Device Correction notification letter to customers. Then, on June 14, 2019, GEHC posted a press release and sent an updated notification letter. These letters included Safety Labels and posters and advised customers to take the following actions:
· 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:
o Labels that warn users of the incorrect and the correct ways to move the warmer.
o 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.
FDA announced that Hamilton Medical AG had developed a new software for the Hamilton-G5 ventilators. The software version 2.80 reduces the likelihood of the ventilator entering an ambient state due to the occurrence of an error leading to a “panel connection lost” error message. Use of the affected device, without the new software, may lead to risk of immediate or long-term consequences to a patient that may result in irreversible harm, injury, or death.
Hamilton Medical AG has received 14 complaints associated with the error message however no patient injury or death have been reported due to the issue.
The Hamilton-G5 is intended for use by health care providers to provide breathing support for adult, pediatric, infant and neonatal patients. This device is powered by AC, and with battery backup in order to protect against power failure or unstable power and to facilitate transport within a hospital or hospital type facility.
In the event of the error occurring, the HAMILTON-G5/S1 ventilator ceases ventilation and enters an ambient state take the following action:
· Check and monitor your patient for safety.
· Provide alternative ventilation immediately.
· Turn off the affected HAMILTON-G5/S1 ventilator.
· Contact your distributor and have the affected HAMILTON-G5/S1 ventilator updated with software version 2.80.
· Please keep this information with your HAMILTON-G5/S1 ventilators instructions for use.
Actions required by the distributors:
· Distribute this Medical Device Safety Alert immediately to all operators of the HAMILTON-G5/S1 ventilators and take the following action:
o Update the HAMILTON-G5/S1 ventilator units with software version 2.80.
o Update the HAMILTON-G5/S1 Operator’s Manual for software version 2.80 as soon as possible upon its availability.
o Update progress of field safety corrective action in the ky2help database.