Recall Z-1967-2023— Vyaire Medical
Class II · Completed
Class II FDA medical device recall by Vyaire Medical, initiated 2023-05-05. It names one FDA 510(k) clearance: K183364. Product: bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator. Reason: 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..
- Recalling firm
- Vyaire Medical
- Classification
- Class II
- Status
- Completed
- Initiated
- 2023-05-05
- Firm location
- Mettawa, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.