bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Summary
The FDA issued a Class II for bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventil by Vyaire Medical. Reason: Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, th.
Details
Source
Device Recall
External ID
Z-1967-2023
Action Date
2023-06-21
Status
Completed
Category
device
Product Description
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Lot/Code Info: UDI/DI 07640149381115 and 07640149388879, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1
Quantity Affected: 392 units
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.
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-05
Company
Mettawa, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Vyaire Medical has 16 FDA actions in our database, including 16 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vyaire Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vyaire Medical have FDA actions?
Vyaire Medical has 16 FDA actions in our database, including 16 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1967-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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