Bellavista 301.100.130Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10190752197701), received between Mar 5, 2024 and Dec 12, 2025 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (4 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Failure to Deliver; Fail-Safe Problem; Failure to Deliver; Fail-Safe Problem

  COMPLAINANT REPORTED THE DEVICE EXPERIENCED MULTIPLE TECHNICAL FAILURES; 300- DEVICE IN FAILSAFE AND 316- FAILURE TO DELIVER THERAPY. COMPLAINANT DID NOT REPORT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794050 ↗
• MalfunctionNov 27, 2024Gas/Air Leak; Gas/Air Leak

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PRODUCT WAS RETURNED, AND AN INVESTIGATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800431 ↗
• MalfunctionNov 22, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE VENT IS GIVING TF 389. CUSTOMER DID THE O2 GAS PATH TEST AND IT APPEARS THE THE O2 SAFETY VALVE IS LEAKING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759648 ↗
• InjuryOct 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000E US 17,3" VENTILATOR DISPLAY BLUESCREEN DURING USE. NO PATIENT HARM WAS REPORTED, AS THEY WERE ABLE TO SWAP THE PATIENT ONTO A NEW VENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20386015 ↗
• MalfunctionSep 16, 2024No Device Output; No Device Output

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA DISPLAYED TF 300 ERROR NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20229460 ↗
• InjurySep 9, 2024No Display/Image; No Display/Image

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000E US 17,3" VENTILATOR HAD AN ISSUE WHEN IT WAS BEING USED ON A PATIENT, ROUGHLY BETWEEN 10 TO 11 A.M. THE UNIT SCREEN WENT COMPLETELY DARK (BLACKOUT), THE TOP 2 LED WAS FLASHING RED AND PRODUCING A LONG CONSISTENCE BEEP NOISE. UNKNOWN PATIENT HARM WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20177605 ↗
• MalfunctionMay 22, 2024No Tactile Prompts/Feedback; No Tactile Prompts/Feedback

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000E 17,3" BASIC VENTILATOR ONLY WANTED TO PERFORM A SHORTENED TEST WHEN BEING PREPARED FOR INVASIVE VENTILATION. IT WAS NOT POSSIBLE TO SELECT ANYTHING ELSE. THIS CONDITION WILL NOT ALLOW THE END USER TO HAVE CHANGES ON SETTINGS AND MAY COMPROMISE THE PATIENT HEALTH. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372402 ↗
• InjuryMay 20, 2024Gas Output Problem; Gas Output Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT BELLAVISTA1000E US 17,3" VENTILATOR HAD TF 271 - "O2 SUPPLY FAIL - NO O2 DOSING POSSIBLE. IT OCCURRED ONCE WHILE ON A PATIENT DURING MULTIPLE ALARMS SUCH AS 258 - DISCONNECTION EXHALATION VALVE, 251 - DISCONNECTION AND 113 - PRESSURE LOW. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353818 ↗
• MalfunctionApr 18, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED TO VYAIRE THAT THE BELLAVISTA STOPPED WORKING PROPERLY IN HIGH FLOW MODE AND THE PATIENT WAS CLOSE TO SATURATION. AFTER SWITCHING OFF THE DEVICE BRIEFLY IN STANDBY MODE AND SWITCHING IT BACK ON, THE FLOW WORKED AS NORMAL, AND THE PATIENT'S SPO2 VALUE STABILIZED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135953 ↗
• InjuryApr 10, 2024No Display/Image; No Display/Image

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING SURGERY THE BELLAVISTA1000E US 17,3" VENTILATOR HAD AN ERROR MESSAGE: "BELLAVISTA DETECTED A USER INTERFACE ISSUE - DECOMMISSION BV" SCREEN.THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079199 ↗
• MalfunctionApr 10, 2024Mechanical Problem; Gas/Air Leak; Mechanical Problem; Gas/Air Leak

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000E US 17,3" VENTILATOR IS GIVING TF 401 (INSPIRATION VALVE OR DEVICE LEAKY) AND 316 (BLOWER FAILURE).FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078798 ↗
• InjuryApr 6, 2024No Display/Image; No Display/Image

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000E US 17,3" VENTILATOR HAD AN ERROR MESSAGE: "BELLAVISTA DETECTED A USER INTERFACE ISSUE - DECOMMISSION BV" SCREEN. FURTHERMORE, PATIENT WAS TRANSFERRED TO ALTERNATIVE VENTILATION AND NO HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19056729 ↗
• MalfunctionMar 26, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED TO VYAIRE MEDICAL THAT LOGS WERE RECEIVED FOR PERSISTENT 388/271 ALARM. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983952 ↗
• MalfunctionMar 26, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED TO VYAIRE MEDICAL THAT LOGS WERE GIVING TF 388. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983893 ↗
• MalfunctionMar 5, 2024Mechanical Problem; Gas/Air Leak; Mechanical Problem; Gas/Air Leak

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000E US 17,3" VENTILATOR HAD TF 300 (DEVICE IN FAILSAFE) ALARM. ALSO FOUND ALARMS 401, 400 (INSPIRATION VALVE OR DEVICE LEAKY), 545 (ASTEPINSPVALVE VALUE OUT RANGE - FAILSAFE) AND 316 (BLOWER FAILURE). THE ERROR WAS FOUND PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838283 ↗