Nellcor Puritan Bennett Inc. (doing business as Covidien LP) recalled its 980 Ventilator Systems with software versions below 2.8 because it may have a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected. This can lead to serious health problems or death if the healthcare provider does not connect the patient to another ventilator or to a different form of breathing support.
The Nellcor Puritan Bennett 980 Ventilator System provides constant breathing support for adults, children, and premature babies that weigh at least 10.6 ounces. The ventilator is used in hospitals or during patient transport.
The units subject to the recall were manufactured and distributed from March 3, 2014 through August 19, 2014.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe