Bellavista recallZ-1966-2023 · Vyaire Medical · initiated May 5, 2023

Why it was recalled

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 root cause category: Nonconforming Material/Component

What the company is doing

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).

Recall details

Recall number

Z-1966-2023

Status

Completed

Initiated by the company

May 5, 2023

Posted by the FDA

Jun 15, 2023

Recalling firm

Vyaire Medical

Quantity

910 units

Product code

CBK

FDA submissions

K183364

Distribution

US Nationwide Distribution

Product description

bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• bellavista 1000

  imtmedical ag · Ventilator, Continuous, Facility Use
  3 recalls219 reports
• Bellavista 301.100.030

  Vyaire Medical, Inc. · Ventilator, Continuous, Facility Use
  1 recall149 reports

Product lines

• BellavistaVyaire Medical, Inc. · 2 models · 164 reports · 1 recall

Other devices under the same FDA submission

1 device cleared under K183364 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• imtmedical pte 301.328.010

  Imtmedical Pte. Ltd. · Ventilator, Continuous, Facility Use
  6 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92243).

• Z-1967-2023 · Completed
  bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator