The Hamilton-C6 Intensive Care Ventilator is intended to provide mechanical ventilation or breathing support for infants (neonatal), children (pediatric) and adult patients. It can provide ventilator support invasively through a tube in the mouth, nose or airway (trachea) or 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.
Hamilton Medical AG is recalling 497 Hamilton-C6 Intensive Care Ventilators after customer complaints revealed a hardware issue with the ventilator’s status indicator board. The status indicator board may become loose, allowing liquid to enter (ingress) between the indicator board and the ventilator’s main board.
The 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.
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.
On August 29, 2022, the FDA identified the recall as Class I, the most serious as use of the devices could cause serious injuries or death.
The ventilators were sold from August 31, 2017 to May 20, 2022.
The FDA has received 128 complaints worldwide, but no injuries or deaths have been associated with the issue.
On June 27, 2022, Hamilton Medical AG issued a Field Safety Notice to healthcare facilities, distributors and service engineers. They 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.
- Though the loose status indicator board may not lead immediately to the ventilator entering an ambient state, the board will be replaced immediately to avoid any risk to patients.
- Make sure to always have an alternative means of ventilation available when using ventilation devices, as stated in the operations manual.
For more information, contact Hamilton Medical AG at +41 58 610 1020 or email@example.com.