A patient not receiving enough oxygen can result in possible injury or death.
Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs.
May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.
Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients.
Potential for delay in treatment of magnesium sulfate in 5% dextrose, that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.
Administration of non-sterile injection products may result in a site-specific or systemic infection, with the potential to cause hospitalization, permanent organ damage, or death.
Problems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator.
May result in delay of treatment, life threatening health consequences that include hypoxia and hypoventilation.
Defect may cause serious adverse health consequences, including hypoxemia and death.
If a tracheal tube kinks, it can deprive the patient of adequate ventilation causing serious patient injury including hypoxic injury and/or anoxia, and death.
Patients may receive a higher than expected tidal
If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
The recommended pump refill date, computed by the Control Unit, may be incorrect.