Vyaire Medical recently announced that its subsidiary ImtMedical has initiated a voluntary field correction for certain BellaVista ventilators.
The company reported a potential issue with BellaVista 1000 and 1000e ventilators that have specific software and configuration combinations that can cease ventilation and generate a technical failure alarm. The issue affects ventilators distributed between Mar. 21, 2019 and Dec. 23, 2021, that have software version 6.0.1600.0 or higher installed, which was deployed in February 2021, and also have the data communication port set to “HL7.”
Vyaire Medical told customers with software version 6.0.1600.0 or higher installed to immediately disable the HL7 data communication if activated. The devices are at risk of unintentional ceasing of ventilation if the data communication is not disabled.
The recall was issued based on reports that some of the ventilators unintentionally ceased ventilation during clinical use and require rebooting to restore ventilation. Vyaire Medical investigated the problem and determined that 1000 and 1000e ventilators software version 6.0.1600.0 or higher installed can have a conflict in memory resource allocation between software tasks when the data communication port is set to “HL7,” which produces the technical failure alarm 305.
There have been no reports related to the issue. The error will not occur is the data communication port is not set to “HL7.”
Vyaire Medical won FDA clearance for the BellaVista 1000e ventilator in November 2019. It is indicated for the integration of high-flow oxygen therapy and advanced synchrony support.