Medtronic PLC has recalled about 650 Puritan Bennett 980 Ventilators because a software glitch may cause the machine to deliver too little oxygen in the neonatal setting. This was the second serious recall of this device in a year.
The Food and Drug Administration (FDA) said Medtronic started notifying hospitals in July of the latest issue, the Minneapolis Star Tribune reports. The FDA classified this as a Class 1 recall—its most serious category—because the lack of oxygen can lead to injuries or death.
The Puritan Bennett 980 is a touchscreen-controlled critical care ventilator intended for use with adults, children, and premature babies in hospitals and during transport. The device was approved by the FDA in February 2014, a year before Medtronic acquired Covidien PLC, the ventilator’s manufacturer.
According to Medtronic, there have been no reports of serious patient harm because of this problem. The recall was initiated after Covidien received reports from the field that one setting on the ventilator —the Volume Control Plus Mode (VC+) — may not deliver as much oxygen as intended when used in combination with another setting that humidifies the air for neonatal patients.
Medtronic has been sending out service engineers to configure the ventilators and remove the NeoMode capability setting, but the company says the device remains safe for all of its other uses on adults and pediatric patients, the Star Tribune reports. “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, Covidien recommends the 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 model ventilators. The FDA notice for that recall said ventilators with older versions of the software may 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,” the recall notice said.
The 657 ventilators included in the current recall were manufactured from March 2014 to 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.
Customers with questions may contact Covidien’s Technical Support Department at 800-255-6774 (option 4, then option 1).
The FDA encourages health care professionals to report adverse events or quality problems with these ventilators through the MedWatch reporting program: www.fda.gov/medwatch/report.htm.