The status indicator board may become loose, allowing liquid to enter (ingress) between the indicator board and the ventilator’s main board. This water ingress may cause the ventilator to have a technical fault and revert to a safety ventilation mode or revert to an ambient state, which means the patient breathes ambient room air with no assistance or support from the machine.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The Hamilton-C6 intensive care ventilator is intended to provide mechanical ventilation or breathing support for infants, children, and adult patients. It is able to provide ventilator support invasively through a tube in the mouth, nose, or airway or non-invasively through a mask placed over the mouth, nose, or face.
When the ventilator enters ambient state, an alternative source of ventilation must be provided immediately or 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.
The Hamilton-C6 ventilator is used by qualified, trained healthcare personnel under the direction of a physician in hospitals and healthcare settings. There have been 128 complaints (worldwide) and no injuries or deaths associated with this issue.
On June 27, Hamilton Medical AG issued a field safety notice via e-mail to healthcare facilities, distributors, and service engineers. The recommended the following actions:
- Check affected ventilators and inform the distributor immediately if loosening of the status indicator board is detected.
- If a loose status indicator board is detected by the user, the front housing of the device will be replaced to prevent water ingress.
- Make sure to always have an alternative means of ventilation available when using ventilation devices, as stated in the operations manual.
- Complete and return the confirmation sheet included with the notice.