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 …