HAMILTON-C6 Intensive Care Ventilator, REF: 160021

Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety Ventilation (blower runs constantly) or Ambient Sate (inspiratory channel/expiratory valves opened; patient breaths room air unassisted) with Panel connection lost message displayed

On 6/27/22 Field Safety Notices were emailed to health care facilities, distributors, and service engineers who were informed to take the following actions: 1) In case of a loose status indicator board observed by the user, the front housing containing the status indicator board shall be replaced. This replacement prevents the water ingress that may lead to ambient state. 2) Check your affected ventilator and inform the distributor immediately if you detect the loosening of the status indicator board. 3) Your local distributor or service engineer will contact you shortly. 4) Loose status indicator board may not lead immediately to an ambient state, however it shall be replaced immediately to avoid any risk to the patient. 5) According to the Operator s manual, make sure to always have an alternative means of ventilation available when using ventilation devices. 6) Complete and return the confirmation sheet. Customers with questions can contact the firm: +41 58 610 10 20, [email protected]