Sam Brusco, Associate Editor02.17.22
The U.S. Food and Drug Administration (FDA) has classified Vyaire Medical’s December 23 recall of bellavista 1000 and 1000e ventilators as a Class I recall. 2,605 devices distributed from January 26, 2017 to December 23, 2021 were subject to the recall.
Thus far there have been 18 complaints and seven injuries reported. No deaths have been reported.
Vyaire recalled the ventilators that had specific software versions and configurations after reports the ventilators failed to ventilate and sounded a technical failure alarm. Devices with software version 6.0.1600.0 or higher may have a memory conflict between tasks when the data communication port is set to “HL7,” initiating technical failure alarm 305. The ventilator may then malfunction or stop.
Customers were urged to immediately disable the HL7 configuration data communication port until updated software is available to solve the issue.
The company released a voluntary field correction for the ventilators earlier this month.
Thus far there have been 18 complaints and seven injuries reported. No deaths have been reported.
Vyaire recalled the ventilators that had specific software versions and configurations after reports the ventilators failed to ventilate and sounded a technical failure alarm. Devices with software version 6.0.1600.0 or higher may have a memory conflict between tasks when the data communication port is set to “HL7,” initiating technical failure alarm 305. The ventilator may then malfunction or stop.
Customers were urged to immediately disable the HL7 configuration data communication port until updated software is available to solve the issue.
The company released a voluntary field correction for the ventilators earlier this month.