Bellavista 301.100.030Recalls & reported problems
Vyaire Medical, Inc. · Adult and pediatric ventilator · Class 2
All models of Bellavista (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Vyaire Bellavista ventilator is a breathing machine for adults and children. Some reports describe screen and display problems, and others describe gas output failures. The 156 reports include no deaths and 10 injuries. The one recall, begun in May 2023 and now closed, concerned a touchscreen that could stop responding during use. Reports rose from 43 in the prior 12 months to 64 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 149
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 10190752197664), received between Mar 5, 2024 and Jun 6, 2026 — classified as 10 injuries, 139 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (26 reports).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- May 5, 2023Class IICompleted
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 problems
Device problems
- Display or Visual Feedback Problem26
- Gas Output Problem21
- Failure to Deliver15
- No Device Output14
- Gas/Air Leak12
- Incorrect Measurement11
- No Display/Image8
- Inaccurate Flow Rate7
Patient problems
- No Clinical Signs, Symptoms or Conditions142
- Insufficient Information8
Recent adverse event reports
The 25 most recent of 149 reports, 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 ↗MalfunctionMar 6, 2026Gas Output Problem
IT WAS REPORTED THAT BEFORE USE, THE DEVICE EXPERIENCED A TECHNICAL FAILURE 379 - "NO O2 DOSING POSSIBLE". COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532766 ↗MalfunctionMar 5, 2026Improper Flow or Infusion
IT WAS REPORTED THAT BEFORE USE, THE DEVICE DISPLAYED A TECHNICAL FAILURE 389 "NO O2 DOSING POSSIBLE". COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24520937 ↗MalfunctionFeb 25, 2026Display or Visual Feedback Problem; Failure to Deliver
CUSTOMER STATED THAT THE DEVICE SHOWED TF 542, 316, 300 ALARMS. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24443341 ↗MalfunctionFeb 23, 2026Inaccurate Flow Rate
CUSTOMER STATED THE DEVICE WAS HAVING FIO2 MISMATCH ISSUES WHILE IN USE ON PATIENT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24420596 ↗MalfunctionFeb 16, 2026Gas Output Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR TRIGGERED A TECHNICAL FAILURE 389 ALARM WHILE PERFORMING O2 GAS PATH TEST. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345565 ↗MalfunctionFeb 6, 2026Display or Visual Feedback Problem; No Flow
COMPLAINANT REPORTED THAT WHILE ON A PATIENT, THE DEVICE STOPPED VENTILATING, ALARMED AND SHOWED AN INTERFACE ERROR. THE COMPLAINANT INDICATED ANOTHER DEVICE WAS OBTAINED TO CONTINUE TREATMENT, WITHOUT ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280362 ↗MalfunctionFeb 3, 2026Erratic or Intermittent Display
THE CUSTOMER REPORTED THAT THE VENTILATOR DISPLAYED A BLUE SCREEN. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251542 ↗MalfunctionFeb 3, 2026Erratic or Intermittent Display
THE CUSTOMER REPORTED THAT THE VENTILATOR SCREEN FLICKERS. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251526 ↗MalfunctionFeb 2, 2026Device Alarm System; Gas Output Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR TRIGGERED AN O2 MISMATCH ALARM. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24236679 ↗MalfunctionJan 29, 2026Infusion or Flow Problem
CUSTOMER STATED THAT THE OCCLUSION ERROR WILL NOT GO AWAY WHILE BEING USED ON A PATIENT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210202 ↗
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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