- Hamilton Medical’s recall of ventilators for a software problem was designated Class I by the U.S. Food and Drug Administration, the agency wrote in a Monday notice.
- Hamilton contacted customers in June after learning that its C1, C2, C3 and T1 ventilators switch to “ambient state” if used in neonates for more than 91 days without a restart. In ambient state, the device sounds an alarm and no active ventilation is provided to patients.
- In light of the fault, which has caused 80 complaints but no injuries or deaths, Hamilton is asking users of its ventilators to regularly restart their devices.
Hamilton sells mechanical ventilators for use in adults, children and infants. The problem that caused the Class I recall happens when the devices “are used for long-term ventilation in neonatal group.” If the ventilation time exceeds 91 days, the devices enter ambient state, causing them to sound an alarm, display a fault message and stop providing active ventilation.
“This may require a health care professional to intervene, provide air supply to the patient with a manual resuscitating device, and use an alternative device. Serious consequences or death may result for patients who do not breathe on their own or do not receive immediate intervention,” the FDA wrote in its Class I recall notice.
The recall affects 21,429 devices distributed in the U.S. between late 2010 and May 2023. The fault is limited to certain versions of the software with the neonatal option installed. Hamilton told users of its C1 and T1 ventilators that updating their devices to version 3.0.0 or higher will prevent the problem.
Users of devices with the fault are advised to restart their ventilators regularly to stop them from going into ambient state. Hamilton recommends restarting devices “during the regular exchange of the breathing circuits,” which typically happens every 28 days. Putting the device on standby will not prevent the fault.