Devices

Hamilton Medical Recalls Ventilators

Hamilton Medical is recalling (Class 1) its software for the Hamilton-C6 Medical Ventilator because the ventilator may fail to restart ventilation if it enters sensor fail mode after open suction is performed and the patient is reconnected. The agency says the recall is a device correction and not a market withdrawal.

A recall notice says affected ventilators may not re-start ventilation if the ventilator is using software versions 1.1.4, 1.1.5, and 1.1.6, and:

The user presses the hard key “O2 enrichment” and disconnects the endotracheal tube from the ventilator circuit for open suctioning.
A sensor error takes place due to an issue such as kinked flow sensor tubing.
The ventilator switches to sensor fail mode.
The patient is re-connected to the ventilator while sensor fail mode is still active.

The device issue may cause serious adverse health consequences, especially for the most vulnerable patients, including hypoventilation, apnea, hypoxemia, bradycardia, hypercarbia, increased intracranial pressure, and death, according to the notice. To date, there has been one reported injury and one report of death.

The device is intended to provide mechanical ventilation or breathing support for children and adult patients. It is used in hospital and health care settings including intensive care, emergency, long term acute care, and recovery rooms.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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