FDA MedWatch - bellavista 1000 and 1000e Series Ventilators by Vyaire Medical:

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TOPIC: bellavista 1000 and 1000e Series Ventilators by Vyaire Medical: Class I Recall - Due to Issues with Software Configurations

AUDIENCE: Patient, Health Professional, Risk Manager, Pulmonary

ISSUE: Vyaire Medical is recalling the bellavista 1000 and 1000e Series Ventilators, with specific software versions and configurations, after reports of ventilators failing to ventilate and generating a technical failure alarm.

Issues with the software version 6.0.1600.0 or higher installed can have a conflict in memory between software tasks when the data communication port is set to "HL7," which produces the technical failure alarm 305.

The use of affected ventilators may cause the ventilator to malfunction or stop, which may cause serious adverse events.

There have been 18 complaints, seven injuries, and no reports of death.

For more information and instructions to follow about this recall, click on the red button "Read Recall" below.

BACKGROUND: The bellavista 1000 and 1000e Series Ventilators are used to assist patient breathing by delivering air, or air with extra oxygen, into the airways or lungs. The ventilators can be used on adult and pediatric patient populations, and optionally, on infant and neonatal patients. 

RECOMMENDATIONS: On Dec. 23, 2021, Vyaire Medical sent an Urgent Medical Device Correction Letter to all affected customers instructing them to:

• Immediately disable the HL7 configuration data communication port until a software update is available to address the issue.
  • Select the Periphery settings.
  • Ensure that Port usage is NOT configured to "HL7".
    • For 13.3" devices, select "IntelliBridge / VueLink" or "SpO2".
    • For 17.3" devices, select "IntelliBridge / VueLink".
  • Check if patient profiles have been stored inside the ventilator with the HL7 protocol activated. If that's the case, renew and store (overwrite) the profiles with the IntelliBridge/VueLink or SpO2 setting. Otherwise, the HL7 protocol would be activated again when choosing a patient profile with HL7 protocol setting.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.