Sam Brusco, Associate Editor08.30.22
The U.S. Food and Drug Administration (FDA) has identified Hamilton Medical’s recall of its HAMILTON-C6 intensive care ventilator (which began June 27) as Class I.
The ventilators were recalled following customer complaints that revealed a hardware issue involving the status indicator board. It may become loose, allowing liquid to enter between the indicator board and the main ventilator board. This ingress can cause a technical fault and reversion to a safety ventilation mode or an ambient state, meaning the patient breathes ambient room air with no assistance or support from the machine.
When the ventilator enters an ambient state, alternative source of ventilation must be immediately provided or interrupted ventilation, brain injury from hypoxia, buildup of carbon dioxide in the blood, other serious injuries, or death may occur.
The recall affects 497 devices in the U.S. distributed between August 31, 2017 and May 20, 2022. Thus far, according to FDA, there have been 128 complaints registered worldwide and no reports of injuries or death.
FDA advised customers to check the affected ventilators and inform the distributor immediately if loosening is detected. If the user detects a loose status indicator board, the device’s front housing will be replaced to prevent water ingress.
The ventilator provides mechanical ventilation or breathing support for infants, children, and adult patients. Ventilator support is provided invasively via a tube in the mouth, nose, or airway, as well an non-invasively through a mask over the mouth, nose, or face.
The ventilators were recalled following customer complaints that revealed a hardware issue involving the status indicator board. It may become loose, allowing liquid to enter between the indicator board and the main ventilator board. This ingress can cause a technical fault and reversion to a safety ventilation mode or an ambient state, meaning the patient breathes ambient room air with no assistance or support from the machine.
When the ventilator enters an ambient state, alternative source of ventilation must be immediately provided or interrupted ventilation, brain injury from hypoxia, buildup of carbon dioxide in the blood, other serious injuries, or death may occur.
The recall affects 497 devices in the U.S. distributed between August 31, 2017 and May 20, 2022. Thus far, according to FDA, there have been 128 complaints registered worldwide and no reports of injuries or death.
FDA advised customers to check the affected ventilators and inform the distributor immediately if loosening is detected. If the user detects a loose status indicator board, the device’s front housing will be replaced to prevent water ingress.
The ventilator provides mechanical ventilation or breathing support for infants, children, and adult patients. Ventilator support is provided invasively via a tube in the mouth, nose, or airway, as well an non-invasively through a mask over the mouth, nose, or face.