The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Names: Vyaire Medical Bellavista 1000 and 1000e Series Ventilators
- Product Codes: See Recall Database Entry
- Catalog Numbers: 301.100.030; 301.100.130
- Distribution Dates: January 26, 2017 to December 23, 2021
- Devices Recalled in the U.S.: 2,605
- Date Initiated by Firm: December 23, 2021
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. When a patient needs oxygen, these ventilators can be used at bedside in hospitals, intensive care (sub-acute) facilities, and can be transferred within a facility.
Reason for Recall
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.
Who May be Affected
- Health care providers using affected bellavista ventilators
- Patients who require care using affected bellavista ventilators
What to Do
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.
The letter also instructed distributors to:
- Notify immediately all affected end-users by providing them with the End-User Notification package (includes the End-User Device Correction Notification and the End-User Device Correction Response FORM).
- Return the completed and signed Distributor Device Correction Response FORM to imtmedical ag.
- If any user facilities have distributed any affected products to other persons or facilities, promptly forward a copy of the End-User Notification package includes the End-User Device Correction Notification and the End-User Device Correction Response FORM) to those recipients. Include contact information of those parties in the Distributor Device Correction Response FORM for device correction tracking purposes and further support.
- For all customers with ventilators containing the software option "Data Communication" and the software version 6.0.1600.0 or higher, please install the software patch to fix the issue as soon as available.
Customers in the U.S. with questions about this recall should contact Vyaire Medical at 833-327-3284 between 5 a.m. and 5 p.m. PST, Monday through Friday, or email GMB-AMS-FSCAresponsecentre@vyaire.com.
- Medical Device Recall Database Entry
- Vyaire Medical Issues Voluntary Correction for Certain bellavista™ Ventilators in Specific Software Configurations
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.