FDA MedWatch - Hamilton-C6 Intensive Care Ventilator by Hamilton Medical AG

Class I Recall - Due to Potential Water Ingress that May Cause Breathing Support to Stop

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Hamilton-C6 Intensive Care Ventilator by Hamilton Medical AG: Class I Recall - Due to Potential Water Ingress that May Cause Breathing Support to Stop  AUDIENCE: Patient, Health Professional, Risk Manager, Pulmonology, Pediatrics ISSUE: 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. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: 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. RECOMMENDATIONS: 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 the company. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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