Hamilton-C1 (ventilator)

2023: Recall of defective devices. They suddenly switch to manual air mode

On October 18, 2023, the United States Food and Drug Administration (FDA) announced the recall of defective ventilator equipment manufactured by Hamilton Medical. The use of defective devices can harm the health of patients or even provoke death.

The problem affects Hamilton-C1, Hamilton-T1 and Hamilton-MR1 devices that are used to support the breathing of adults, children, infants and newborns. The equipment can be used during intensive care, as well as when transporting patients in or outside healthcare facilities.

Hamilton-C1

The problem is due to the fact that electrolyte leakage to the control board can occur from the capacitors of ventilators. This can cause a short circuit and then cause problems. In particular, in some cases, the message "Real time clock failure" is shown: this malfunction is not critical and will not have serious consequences for patients.

However, a short circuit can also trigger spontaneous activation of Ambient State mode, in which the device does not provide active ventilation. For patients who do not breathe on their own, it can cause deterioration or death. Therefore, when a notification appears about the transition of the device to Ambient State mode, medical workers should immediately ensure the supply of air to the patient using a manual resuscitation device and use another ventilator.

The recall includes Hamilton-C1/T1/MR1 devices shipped from July 28 to August 8, 2020. As of the beginning of December 2023, there were no reports of deaths associated with the use of these devices.^[1]

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