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Puritan Bennett 980 Ventilators by Covidien: Class I Recall - Amount of Air Delivered May Be Lower Than Programmed

Audience: Risk Manager, Surgery, Critical Care Medicine, Nursing, Pediatrics

[Posted 09/02/2015]

ISSUE: When the ventilator is in neonatal Volume Control Plus (VC+) mode with active humidification, a software error may cause the amount of air being delivered to the patient (tidal volume) to be lower than the amount programmed by the clinician. If a patient does not receive the amount of air set on the machine, they may need to be removed from the ventilator and placed on a different system. A patient not receiving enough oxygen can result in possible injury or death. See the Recall Notice for a list of part and lot numbers.

BACKGROUND: The Puritan Bennett 980 (PB980) Ventilator System provides constant breathing support for adults, children, and premature babies weighing at least 10.6 ounces. The ventilator is used in hospitals or during patient transport.

RECOMMENDATION: On July 17, 2015, Covidien sent an Urgent: Field Corrective Action Notice to customers informing them that Covidien intends to implement a software update to correct the error. Service engineers will contact customers to help coordinate this process. Until the update is implemented, Covidien recommends the following:

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[09/02/2015 - Recall Notice - FDA]

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