Hamilton Medical recently issued a field safety notice to warn on issues with some of its Hamilton-C6 ventilators.
Analysis of customer complaints revealed a hardware issue related to the status indicator board on the C6 ventilators. The board can become loose and may result in a loose contact to the mainboard and potential oxidation of the contact due to the ingress of water.
The defective contact results in a detected technical fault within a very short time, leading to an overflow of log entries forcing the ventilator into “safety ventilation” or “ambient state with panel connection lost” messages displayed.
According to the warning, dated June 10, 2022, Hamilton’s risk assessment concluded the issue to be “an almost impossible situation” but, for a passive patient, an ambient ventilation state may lead to a serious deterioration in the state of health. In case such a situation occurs, the ventilator displays the high-level alarm (audible and visible) to make the defect highly detectable.
Hamilton was informed that, in Canada, one ambient status was detected while a status indicator board was loose. To date, there has been no reported patient harm.
The warning was issued to all healthcare facilities using the Hamilton-C6 ventilators, including intensive care wards, intermediate care wards, emergency wards, long-term acute care hospitals and recovery rooms. Additionally, further recipients include all distributors of Hamilton-C6 ventilators and their service engineers.
Hamilton told users of its C6 ventilators that, in case of a loose status indicator board, the front housing containing the status indicator board should be immediately replaced. The replacement prevents the water ingress that may lead the devices into a potentially problematic ambient state.
The company’s notice also said that a service engineer will contact the affected customers shortly. Users are also urged to ensure that they have an alternative means of ventilation available at all times.