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.
- Product Name: HAMILTON-C6 Intensive Care Ventilator
- Product Model Numbers: See Recall Database entry
- Devices Recalled in the U.S.: 497
- Dates distributed: August 31, 2017 to May 20, 2022
- Date Initiated by Firm: June 27, 2022
The HAMILTON-C6 Intensive Care Ventilator is intended to provide mechanical ventilation or breathing support for infants (neonatal), children (pediatric), and adult patients. It is able to 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.
Reason for Recall
Hamilton Medical AG is recalling the HAMILTON-C6 Intensive Care Ventilator 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. 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.
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.
There have been 128 complaints (worldwide) and no injuries or deaths associated with this issue.
Who May Be Affected
- Healthcare personnel who care for patients receiving breathing support using the HAMILTON-C6 Intensive Care Ventilator.
- Patients who receive ventilation or breathing support from the HAMILTON-C6 Intensive Care Ventilator.
What to Do
On June 27, 2022, Hamilton Medical AG issued a Field Safety Notice via email 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.
- 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 Hamilton Medical AG at: +41 58 610 1020 or firstname.lastname@example.org.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.