In December 2021, imtmedical ag, a subsidiary of Vyaire Medical, initiated a voluntary field correction for certain bellavista™ ventilators. With specific software version and configuration combinations, the ventilators can cease ventilation and generate a technical failure alarm 305.
There is a potential issue with bellavista™ 1000 and 1000e ventilators 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”. Customers with software version 6.0.1600.0 or higher installed have been notified by Vyaire to immediately disable the HL7 data communication if activated. If the HL7 data communication is not disabled, such devices are at risk of the reported unintentional ceasing of ventilation.
This decision is based on the receipt of reports that some bellavista™ 1000 and 1000e ventilators have unintentionally ceased ventilation during clinical use and require rebooting to resume ventilation due to a software issue. An internal investigation determined that bellavista 1000 and 1000e ventilators with 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”. The ventilator notifies the user of the issue by triggering technical failure alarm 305 indicating an interruption in the communication between the user interface controller (EPC) and the ventilation controller (CFB).
No patient harm has been reported related to this issue. If clinicians operate a bellavista™ ventilator and do not set Data Communication port to “HL7”, this error will not occur. Therefore, Vyaire supports the continued use of these devices and directs customers to follow the instructions provided in the Company’s correction notification to immediately disable the HL7 data communication if activated while the company develops and deploys a software update to address the issue, anticipated in Q1 of calendar year 2022.
The affected ventilators were distributed to medical facilities in the US between 3/21/19 through 12/23/21 located in the following states: AL, CA, CO, CT, DC, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OK, PA, PR SD, TX, VA, WA, WI and WV.
US customers with questions about this correction should call 833-327-3284 between 5 am and 5 pm PST Monday through Friday, or email GMB-AMS-FSCAresponsecentre@vyaire.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
At Vyaire, patient safety is of the utmost importance, and this voluntary correction is part of their commitment to the highest quality standards for the people who rely on their technology around the world.
Original notice and updates at FDA