Smiths Medical issues correction for paraPAC Plus P300, P310 ventilators

Smiths Medical is correcting paraPAC Plus P300 and P310 ventilator due to a risk of inadvertent movement of the device’s tidal volume knob. When the knob is set at high (1000 – 1500 ml) or low (70 – 150 ml), the knob may move away from the original setting on its own. If the tidal volume knob moves, it may cause the patient to experience delayed therapy, too much tidal volume or not enough tidal volume.

The use of affected product may cause serious adverse health consequences, including injury from air pressure (barotrauma), too much ventilation (hyperventilation), not enough ventilation (hypoventilation), a build up of carbon dioxide (hypercarbia) or acid (acidosis) in the body, not enough oxygen (hypoxia), slowed heart beat (bradycardia), low blood pressure (hypotension), a sudden stop of the heart and lungs (cardiorespiratory arrest), and death.

There have been no reported injuries and no reports of death.

Device use
Smiths Medical PneuPAC paraPAC Plus P300 and P310 Ventilators are gas-powered emergency and transport portable ventilators, including in vehicles such as airplanes and helicopters. They are suitable for emergency use at an accident scenes and transports between hospitals or within a hospital or medical facility. These ventilators are intended to provide ventilatory support for adults, children, and infants (above approx. 10 kg).

The paraPAC Plus devices also provide free flow oxygen therapy and continuous positive airway pressure (CPAP) therapy for spontaneously breathing patients. The devices can also be used in emergency situations to provide ventilatory support for CPR resuscitation.

ParaPAC Plus ventilators should only be used under the constant supervision of trained health care professionals. U.S. Food and Drug Administration