Class 2 Device Recall vyaire MEDICAL

• Date Initiated by Firm: May 05, 2023
• Date Posted: June 15, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1967-2023
• Recall Event ID: 92243
• 510(K)Number: K183364
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
• Code Information: UDI/DI 07640149381115 and 07640149388879, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1
• Recalling Firm/ Manufacturer: Vyaire Medical; 26125 N Riverwoods Blvd; Mettawa IL 60045-3420
• Manufacturer Reason for Recall: Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm notified its consignees by email on 04/27/2023. The notice explained the issue, the risk to health and requested the following: ACTIONS TO BE TAKEN BY CONSUMERS/END USERS 1. Confirm receipt and thoroughly review the contents of the Customer Notification package. 2. If affected devices are transferred to another location or organization, forward the complete Customer Notification package to the respective users. 3. To reduce the change that the AppHang error will occur, Vyaire recommends that when the )2 suction maneuver is active, the end user should not attempt to activate any controls or screens until: The O2 suction maneuver has timed or The O2 suction maneuver has been aborted by selecting the O2 suction button again to turn it off. Vyaire further recommends the following: User re-configures the screen to remove the circuit monitoring tile, if applicable. User does not connect anything to either of the two USB ports on the left side of the ventilator during patient ventilation. For more detailed instructions, please refer to Appendix A. Following these steps will help to reduce the likelihood of the AppHang occurring. 4. When transitioning between ventilation modes, always check and confirm the proposed settings. The proposed settings are based on the current level of support provided in the active mode at the time of the mode change. Special attention should be given when transitioning back from a spontaneous breathing mode such as Pressure Support Ventilation (PSV).
• Quantity in Commerce: 392 units
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CBK