A number Covidien Puritan Bennett 980 Ventilator System units have been recalled because 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.
Lots with product codes 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, and 980N3ENDIUUS are affected by the recall. These ventilators were manufactured March 2014 to June 2015 and were distributed from March 1, 2014 to June 17, 2015. A total of 657 ventilators were recalled in the U.S.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. When the ventilator is in neonatal Volume Control Plus (VC+) mode with active humidification, a software error may result in the amount of air being delivered to the patient to be lower than the amount programmed by the clinician. If a patient does not receive the programmed amount of air, the patient may need to be removed from the ventilator and placed on a different system. An inadequate amount of oxygen can result in injury or death.
This is a Class 1 recall, the Food and Drug Administration’s most serious type of recall, reserved for situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
On July 17, 2015, Covidien sent an urgent corrective action notice to customers informing them of a software update to correct the error. Service engineers will contact customers to coordinate this process. Until the update is implemented, Covidien recommends that health care facilities assess all neonatal patients on a PB980 ventilator using VC+ in NeoMode to ensure the patient is receiving sufficient ventilation.
Clinically stable patients can be transferred to an alternative ventilator. Patients can remain on PB980 ventilators until it is safe to transfer them to a different ventilator, the FDA said. Customers with questions may contact Covidien’s Technical Support Department at 800-255-6774 (option 4, then option 1).
Universal model ventilators being used for adult or pediatric patients may remain in use until it is safe to remove the ventilator from use and change the configuration to disable the NeoMode feature.
Health care professionals and consumers may report adverse events or quality problems they experience with these products through the FDA’s MedWatch reporting program: www.fda.gov/medwatch/report.htm. Reports can be made to the FDA online, by mail, or by fax.