Medtronic Recall Ventilators. For the second time within a year, Medtronic PLC has recalled Puritan Bennett 980 ventilators; this time because a software glitch may cause the machine to deliver too little oxygen in the neonatal setting.
Medtronic began notifying hospitals in July of the latest problem, the Minneapolis Star Tribune reports. The Food and Drug Administration categorized this as a Class 1 recall, the most serious of the FDA’s three recall categories. The lack of oxygen can lead to permanent injury or death.
The Puritan Bennett 980 (PB980) Ventilator System is a touchscreen-controlled system that 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. In neonatal Volume Control Plus (VC+) mode with active humidification, a software error may result the PB980 delivering less air to the patient than the amount programmed by the clinician. A patient who does not receive the programmed amount of air may need to be removed from the ventilator and placed on a different system.
Medtronic said it has not received any reports of serious patient harm because of the problem. Covidien initiated the recall after receiving reports from the field that the Volume Control Plus Mode (VC+) setting may not deliver as much oxygen as intended when used in combination with another setting that humidifies the air for neonatal patients.
To correct the problem, Medtronic is sending service engineers to hospitals to remove the NeoMode setting from the ventilators, but the company says the ventilator remains safe for all other uses for adult and pediatric patients, according to the Star Tribune. “The issue identified with the VC+ ventilation setting in NeoMode does not impact the PB980’s ability to deliver accurate volumes to pediatric and adult patients,” Medtronic said in an e-mailed statement. Until the update is implemented, the company 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.
In October 2014, Covidien recalled 324 of the same ventilator model. The FDA said ventilators with older versions of the software could have a glitch that could cause the machine to stop working if the air and oxygen supply lines were disconnected and then reattached. “This can lead to serious health problems or death if the health care provider does not connect the patient to another ventilator or to a different form of breathing support,” according to the recall notice.
The current recall includes 657 ventilators that were manufactured between March 2014 and June 2015 and were distributed from March 1, 2014 to June 17, 2015. Product codes 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, and 980N3ENDIUUS are affected by the recall. Covidien’s Technical Support Department will take customer questions about the recall at 800-255-6774 (option 4, then option 1).
The FDA encourages health care professionals and to report adverse events or quality problems with these ventilators through the MedWatch reporting program: www.fda.gov/medwatch/report.htm.