BellavistaRecalls & reported problems across all models
Vyaire Medical, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 164
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 1
We found 2 models of Bellavista by Vyaire Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 164 adverse event reports in the FDA's MAUDE database, received between Mar 5, 2024 and Jun 6, 2026 — classified as 15 injuries, 149 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (27 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Bellavista recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 5, 2023Completed
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.
Z-1966-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported Bellavista problems
Device problems
- Display or Visual Feedback Problem27
- Gas Output Problem22
- Failure to Deliver19
- Gas/Air Leak16
- No Device Output15
- Incorrect Measurement11
- No Display/Image11
- Fail-Safe Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions156
- Insufficient Information9
Bellavista models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bellavista 301.100.030Ventilator, Continuous, Facility Use1 recall149 reports
- Bellavista 301.100.130Ventilator, Continuous, Facility Use15 reports
Recent Bellavista adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT THE DEVICE EXPERIENCED INTERFACE ISSUES AND DISPLAYED A DECOMMISSION SCREEN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THERE WAS NO ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25418975 ↗MalfunctionMay 4, 2026Gas Output Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR TRIGGERED A TECHNICAL FAILURE 300, 400, 545 ERROR. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25072718 ↗MalfunctionApr 21, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT THE DEVICE SHOWED A BLUE SCREEN. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24937802 ↗MalfunctionApr 16, 2026Failure to Deliver; Infusion or Flow Problem; Reset Problem
IT WAS REPORTED THAT THE DEVICE EXPERIENCED A LONG PAUSE WITH INSPIRATORY AND EXPIRATION AND TECHNICAL FAILURE ALARMS 300, 316 AND 545. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897489 ↗MalfunctionApr 13, 2026Inadequate User Interface
IT WAS REPORTED THAT THE DEVICE SHOWED A BLUE SCREEN. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860900 ↗MalfunctionApr 6, 2026Display or Visual Feedback Problem; Inadequate User Interface
IT WAS REPORTED THAT WHILE VENT WAS IN USE ON A PATIENT, WHEN THE VENT SHOWED A BLUE SCREEN AND DID NOT APPEAR TO BE VENTILATING. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794226 ↗MalfunctionApr 6, 2026Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR'S DISPLAY IS BLACK, AND UPON CONNECTION TO A POWER SOURCE, IT EXHIBITS A FLASHING RED LIGHT FOLLOWED BY YELLOW, ACCOMPANIED BY CONTINUOUS BEEPING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792631 ↗MalfunctionApr 6, 2026Gas/Air Leak
IT WAS REPORTED THAT DURING USE ON A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE EXPERIENCED AN O2 LEAKAGE FAILURE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792625 ↗MalfunctionApr 3, 2026Application Program Freezes or Fails to Launch
COMPLAINANT REPORTED A FROZEN SCREEN AND BROKEN O2 FILTER ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783527 ↗MalfunctionApr 2, 2026Circuit Failure
IT WAS REPORTED THAT THE VENTILATOR FLOW SENSOR FAILED CIRCUIT TEST WHILE ON A PATIENT. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769213 ↗MalfunctionMar 25, 2026Display or Visual Feedback Problem; Failure to Deliver
CUSTOMER REPORTED THE VENT WAS GIVING OFF TECHNICAL FAILURE ALARMS 300, 316, 545. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691397 ↗MalfunctionMar 20, 2026Incorrect Measurement
IT WAS REPORTED THAT THE DEVICE SHOWED INACCURATE OXYGEN READINGS. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651056 ↗MalfunctionMar 20, 2026Incorrect Measurement
IT WAS REPORTED THAT THE DEVICE WAS SHOWING INACCURATE OXYGEN READINGS. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651047 ↗MalfunctionMar 14, 2026Gas Output Problem
CUSTOMER REPORTED GETTING THE TECHNICAL FAILURE 271 AND 388 ALARMS ON THE UNIT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24600415 ↗MalfunctionMar 12, 2026Gas Output Problem
IT WAS REPORTED THAT THE DEVICE ALARMED TECHNICAL FAILURE 389, NO O2 DOSING POSSIBLE. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24586395 ↗
Other Vyaire Medical, Inc. products
All Vyaire Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page