Some ventilators from Imtmedical, a subsidiary of Vyaire Medical, have unintentionally stopped ventilation during use and require rebooting to resume ventilation because of a software issue, according to a Feb. 4 news release from the FDA.
Four things to know:
1. Vyaire Medical said users should disable Bellavista 1000 and 1000e ventilators that have software version 6.0.1600.0 or higher installed and also have the data communication port set to "HL7." Customers with software version 6.0.1600.0 or higher installed have been notified to immediately disable the HL7 data communication.
2. The company is developing a software update to address the issue, but advises customers to follow instructions provided in its correction notice to disable the HL7 data communication if activated.
3. Affected ventilators were distributed to medical facilities located in 27 states and Washington, D.C., between March 21, 2019, and Dec. 23, 2021.
4. No patient harm related to the issue has been reported thus far.