Hamilton Medical AG issued a recall of the Hamilton C6 ventilator after customer complaints revealed a hardware issue with the ventilator’s status indicator board, according to an FDA alert. The device is approved for both invasive and noninvasive ventilation to neonatal, pediatric, and adult patients.
The FDA reports that the status indicator board on the Hamilton C6 ventilator 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,” according to the FDA.
The FDA added that, 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 hypoxia, hypercarbia, other serious injuries, or death.
There have been 128 complaints (worldwide) and no injuries or deaths associated with this issue, the FDA said.
Hamilton C6 Recall Recommendations
According to the FDA alert, Hamilton Medical AG issued a Field Safety Notice on June 27, 2022 to healthcare facilities, distributors, and service engineers recommending 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.
- Complete and return the confirmation sheet included with the notice.
- Customers with questions or concerns about this recall should contact the company.
More information is available on the FDA website.