bellavista 1000Recalls & reported problems
imtmedical ag · The bellavista ventilator is intended to provide positive pressure ventilator support to adults and pediatrics (IBW greater than 6 kg). Environment of use: Hospitals, sub-acute care facilities and intra-hospital transfer. It is inteded for use by qualified, trained personnel under the directionof a physician. · Class 2
Quick summary
This bellavista 1000 ventilator has 225 adverse event reports: 219 describe malfunctions and 6 describe injuries, with no deaths. Many malfunction reports describe the device failing to deliver gas, showing no output, or freezing or not responding on its screen, and some list error messages. There are 3 recalls naming this device, all closed; they concern a touchscreen that can stop responding and a possible interruption of ventilation under certain conditions.
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
- 219
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 219 adverse event reports that list this exact device (DI 07640149381115), received between Feb 15, 2022 and Aug 27, 2026 — classified as 6 injuries, 213 malfunctions.
The most frequently reported specific device problem is “Gas Output Problem” (58 reports).
3 FDA recall records 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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-1967-2023 · Root cause: Nonconforming Material/Component · FDA record ↗
- 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 · FDA record ↗
- Dec 20, 2021Terminated
Potential cessation in ventilation can occur under specific conditions.
Z-0622-2022 · Root cause: Software change control · FDA record ↗
Most reported problems
Device problems
- Gas Output Problem58
- Failure to Deliver30
- No Device Output17
- Display or Visual Feedback Problem16
- Improper Flow or Infusion12
- No Display/Image12
- Unexpected Shutdown12
- Inadequate User Interface9
Patient problems
- No Clinical Signs, Symptoms or Conditions201
- Insufficient Information15
- Low Oxygen Saturation3
Recent adverse event reports
The 25 most recent of 219 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Gas Output Problem
It was reported that the device experienced a no O2 dosing technical failure. There was no patient involvement indicated related to the reported malfunction.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479729 ↗MalfunctionJun 30, 2026Output Problem
IT WAS REPORTED THAT THE DEVICE EXPERIENCED TECHNICAL FAILURE 542 "SCALED VENTILATION SENSOR VALUE OUT OF RANGE". NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670347 ↗MalfunctionJun 30, 2026Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THE DEVICE SHOWED "FROZEN SCREEN." COMPLAINANT REPORTED WHEN REMOVING THE DEVICE, IT ALARMS LIKE NORMAL BUT ONCE RECONNECTED, THE SCREEN DOES NOT RESPOND TO TOUCH. ADDITIONALLY, THE DEVICE "LOCKS UP" WHEN POWERING ON. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25669213 ↗MalfunctionJun 24, 2026Failure to Deliver
IT WAS REPORTED THAT THE DEVICE SHOWED TECHNICAL FAILURE 316- FAILURE TO DELIVER. THERE WAS NO INDICATED PATIENT INVOLVEMENT RELATED TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25612777 ↗MalfunctionMay 21, 2026Gas Output Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR EXHIBITED TECHNICAL FAILURES, SPECIFICALLY ERROR MESSAGES 300, 401, 316, AND 346.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247344 ↗MalfunctionMay 18, 2026Display or Visual Feedback Problem; No Flow
THE VENTILATOR IN USE FOR A TRACHEOSTOMISED PATIENT SUDDENLY CEASED OPERATION AND DISPLAYED A ?USER INTERFACE ISSUE? ALARM ON THE SCREEN. IMMEDIATE MANUAL VENTILATION USING AN AMBUBAG WAS INITIATED BY THE NURSE IN CHARGE WHO WITNESSED THE INCIDENT. THE RESPIRATORY THERAPIST PROMPTLY REPLACED THE VENTILATOR WITH ANOTHER DEVICE. THE PATIENT REMAINED STABLE THROUGHOUT THE EVENT, WITH NO EPISODES OF OXYGEN DESATURATION OR SIGNS OF RESPIRATORY DISTRESS OBSERVED. NO FURTHER COMPLICATIONS WERE NOTED FOLLOWING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25201172 ↗MalfunctionMay 15, 2026Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE VENTILATOR SHUTDOWN AUTOMATICALLY WHILE IN USE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25184279 ↗MalfunctionMay 14, 2026Failure to Deliver
IT WAS REPORTED THAT BEFORE USE, THE DEVICE EXPERIENCED A TECHNICAL FAILURE 316. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174933 ↗MalfunctionMay 12, 2026Gas Output Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR EXHIBITED TECHNICAL FAILURES, SPECIFICALLY ERROR MESSAGES 316, 400, 401, AND 545. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149008 ↗MalfunctionMay 5, 2026Gas Output Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR TRIGGERED A TECHNICAL FAILURE 401 AND 316 ALARM. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085862 ↗MalfunctionMay 4, 2026Gas Output Problem
IT WAS REPORTED THAT DURING USE ON A PATIENT (AGE & GENDER UNKNOWN), THE USER WAS NOT SEEING ANY VOLUMES ON THE VENTILATOR. THE PATIENT WAS MOVED TO ANOTHER VENTILATOR WITH NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073068 ↗MalfunctionMay 1, 2026Gas Output Problem
IT WAS REPORTED THAT DURING USE, THE DEVICE EXPERIENCED ISSUES WITH NO O2 DOING POSSIBLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 25059233 ↗MalfunctionApr 27, 2026Gas Output Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR TRIGGERED A TECHNICAL FAILURE 316 AND 401 ALARM. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25002118 ↗MalfunctionApr 21, 2026Gas Output Problem
IT WAS REPORTED THAT DURING USE, THE DEVICE DISPLAYED AN O2 MISMATCH ALARM. THE PATIENT WAS MOVED TO ANOTHER DEVICE WITH NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24937780 ↗MalfunctionApr 14, 2026Improper Flow or Infusion
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE VENTILATOR EXPERIENCED A TECHNICAL FAILURE 300 "DEVICE IN FAILSAFE MODE". 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 24877910 ↗MalfunctionApr 14, 2026Gas Output Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR TRIGGERED A TECHNICAL 389 ALARM. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873963 ↗MalfunctionApr 14, 2026Gas Output Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR TRIGGERED A 389 TECHNICAL FAILURE ALARM. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873942 ↗MalfunctionApr 9, 2026Unexpected Shutdown
THE CUSTOMER REPORTED THAT THE DEVICE WAS SHUTTING DOWN DURING USE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24828250 ↗MalfunctionApr 8, 2026Failure to Deliver
THE CUSTOMER REPORTED THAT THE VENTILATOR TRIGGERED A 401 AND 316 ALARM. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817578 ↗MalfunctionMar 31, 2026Gas Output Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR EXHIBITED TECHNICAL FAILURE 388, "NO O2 DOSING POSSIBLE" ALARM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748682 ↗MalfunctionMar 31, 2026Gas Output Problem
IT WAS REPORTED THAT THE DEVICE TRIGGERED A "NO O2 DOSING POSSIBLE" ALARM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748477 ↗MalfunctionMar 31, 2026Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR DISPLAYS A GREEN SCREEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746725 ↗MalfunctionMar 25, 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 24691379 ↗MalfunctionMar 13, 2026Gas/Air Leak
IT WAS REPORTED THAT BEFORE USE, THE DEVICE EXPERIENCED AN O2 ALARM FAULT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24598933 ↗MalfunctionMar 13, 2026Gas Output Problem
CUSTOMER REPORTED AN FIO2 MISMATCH ERROR. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24593987 ↗
Other Ventilator, Continuous, Facility Use devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.