The FDA issued a notice labeling a recall of the Hamilton Medical Hamilton-C6 intensive care ventilator as Class I, the most serious kind.
Hamilton Medical initiated the recall for its ventilator on June 27, 2022. The recall is due to a hardware issue with the ventilator’s status indicator board. It covers 497 devices distributed between Aug. 31, 2017, and May 20, 2022. To date, Hamilton received 128 complaints related to the issue, with no deaths or injuries reported.
According to the FDA notice, customer complaints revealed that the Hamilton-C6 ventilator’s status indicator board may become loose, allowing liquid to enter (ingress) between the indicator board and the ventilator’s main board.
Water ingress may cause the ventilator to have a technical fault. This would revert the device to a safety ventilation mode or revert to an ambient state. In such a state, the patient breathes ambient room air with no assistance or support from the machine.
If the ventilator enters an ambient state, an alternative source of ventilation must be provided immediately. If an alternative source isn’t provided, the patient may experience interrupted ventilation, brain injury caused by lack of oxygen to the brain (hypoxia), buildup of carbon dioxide in the blood (hypercarbia), other serious injuries, or death.
Hamilton Medical designed its ventilator to provide mechanical ventilation or breathing support for infants, children and adult patients. It provides support invasively through a tube in the mouth, nose or airway. The Hamilton-C6 intensive care ventilator can also offer support non-invasively through a mask placed over the mouth, nose or face.
The Hamilton-C6 ventilator is used by qualified, trained healthcare personnel under the direction of a physician in hospitals and healthcare settings.