Software Issues Result in Class I Recall of Nellcor Puritan Bennett, 980 Ventilator System

A Class I recall has been issued for Covidien’s Nellcor Puritan Bennett 980 Ventilator System, Anesthesiology News reports. According to a U.S. Food and Drug Administration (FDA) safety alert, the products were recalled over a software issue and affects systems with software versions below 2.8 distributed between March 3, 2014 and August 22, 2014.

The recalled ventilator system is used to provide breathing support. It is used in hospitals and during patient transport in children, adults and premature babies weighing at least 10.6 ounces. The software issue causes the ventilator to stop working when the air and oxygen supply lines are disconnected and then reconnected, the FDA safety alert states. This could result in serious injuries or death.

“Puritan Bennett 980 Ventilator Systems with software versions below 2.8 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 recall notice states.
A Class I recall is the FDA’s most serious recall status; it indicates that exposure to the recalled product can lead to serious injury or death. An Urgent Field Corrective action letter dated October 3, 2014 was sent to Covidien customers. The systems’ software will be updated by a representative, the safety alert says.

According to the recall notice, the letter also highlights important safety reminders. Customers are urged to always follow the operator’s manual instructions and maintain the system as suggested in the manual. Patients on ventilators should be closely watched and another source of breathing support should always be kept nearby when a ventilator is used. Additionally, two gas sources should be connected to the ventilator in case one malfunctions.

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