Smiths Medical has issued a correction for paraPAC Plus P300 and P310 ventilators due to “inadvertent tidal volume knob movement.”
The affected devices should be inspected to determine if the advices are affected by rotating the tidal volume knob to both its lowest and highest positions to see if it stays in position. If the knob moves from where it was set, “the product should be removed from use until it can be repaired.” Smiths also emphasizes that you should “not attempt to use or repair the affected product.”
If the tidal volume knob moves while in use, “it may cause the patient to experience delayed therapy, too much tidal volume or not enough tidal volume.” This could cause “serious adverse health consequences, including injury from air pressure (barotrauma), too much ventilation (hyperventilation), not enough ventilation (hypoventilation), a buildup of carbon dioxide (hypercarbia) or acid (acidosis) in the body, not enough oxygen (hypoxia), slowed heartbeat (bradycardia), low blood pressure (hypotension), a sudden stop of the heart and lungs (cardiorespiratory arrest), and death.” There have been no reported injuries or deaths at the time of this writing.
The ventilators in question 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.”
