VELA 16531-00 (UDI 10846446001501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 198 adverse event reports that list this exact device (DI 10846446001501), received between Nov 2, 2018 and Apr 16, 2024 — classified as 72 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (155 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 198 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO VYAIRE MEDICAL THE CUSTOMER IS UNABLE TO SET VOLUME ON THE VELA VENTILATOR UNIT. THE VENTILATOR WAS ON A PATIENT WHEN THE REPORTED ISSUE OCCURRED. PATIENT INJURY OR HARM IS UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19120549 ↗
• MalfunctionApr 10, 2024Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO VYAIRE THAT THE VELA HAD A BAD TURBINE TRANSDUCER ON THE MAIN BOARD. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19079877 ↗
• MalfunctionNov 29, 2023No Pressure; No Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS NO PRESSURE. FURTHERMORE THERE IS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18235098 ↗
• MalfunctionOct 27, 2023Connection Problem; Connection Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAD A CIRCUIT DISCONNECT ALARM BACK ON (B)(6) WHILE ON A PATIENT USE. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THIS EVENT. CUSTOMER CONFIRMED THAT THE UNIT WAS REPLACED BY A DIFFERENT VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026343 ↗
• MalfunctionOct 10, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAD PROBLEMS WITH VTI (TIDAL VOLUME OF INSPIRATION) AND VTE (TIDAL VOLUME OF EXPIRATION) THAT WERE INACCURATE. VTI READS 439ML AND THE VTE READS 397ML. FURTHERMORE, THERE IS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909015 ↗
• MalfunctionSep 26, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR IS GIVING A MOTOR FAULT AFTER POWERING ON. AT THIS TIME, THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822147 ↗
• MalfunctionAug 28, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAD A VENT INOP (INOPERABLE) AND XDCR (TRANSDUCER FAULT) ALARMS. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT. THE CUSTOMER CONFIRMED THAT THIS VENT IS IN LONG TERM STORAGE IN CASE OF ANOTHER PANDEMIC AND HE PERFORMS AN OPERATIONAL VERIFICATION ON IT EVERY 6 MONTHS TO ENSURE FUNCTIONALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630359 ↗
• InjuryJul 28, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT AN O2 SENSOR ERROR HAS OCCURRED ON THE VELA VENTILATOR WHEN SET TO 100% O2 DURING PATIENT USE. FURTHERMORE, THE PATIENT WAS TRANSFERRED TO ANOTHER DEVICE AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17411141 ↗
• MalfunctionApr 20, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WERE LOW VOLUMES ON THE MONITOR OF THE VELA VENTILATOR. THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS OF THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782076 ↗
• MalfunctionApr 3, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT WHILE THE VELA VENTILATOR WAS RUNNING, THE TRANSDUCER FAULT ALARM WAS TRIGGERED DURING SET UP PRIOR TO PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16671097 ↗
• MalfunctionMar 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT IMMEDIATELY WHEN THE VELA VENTILATOR HAS HIGH RATE AND XDCR (TRANSDUCER) FAULT ALARMS.AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16556379 ↗
• InjuryMar 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT IMMEDIATELY WHEN THE VELA VENTILATOR WAS POWERED ON, LOW VE (MINUTE VENTILATION), HIGH PIP (PEAK INSPIRATORY PRESSURE), AND HIGH RATE ALARMS WERE TRIGGERED DURING PATIENT USE. FURTHERMORE, THE PATIENT WAS TRANSFERRED TO ANOTHER DEVICE AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16556280 ↗
• MalfunctionMar 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT IMMEDIATELY WHEN THE VELA VENTILATOR WAS POWERED ON, LOW PIP (PEAK INSPIRATORY PRESSURE), HIGH RATE AND XDCR (TRANSDUCER) FAULT ALARMS WERE TRIGGERED DURING SET UP PRIOR TO PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16556125 ↗
• MalfunctionMar 16, 2023Intermittent Continuity; Mechanical Problem; Intermittent Continuity; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A TRANSDUCER ALARM HAS OCCURRED ON THE VELA VENTILATOR. THERE WAS NO PATIENT INVOLVED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16556080 ↗
• MalfunctionMar 5, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS TRANSDUCER FAULT. FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483497 ↗
• InjuryMar 5, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAD A LOW PIP (PEAK INSPIRATORY PRESSURE), HIGH RATE, LOW VE (MINUTE VENTILATION) AND MOTOR FAULT ALARMS WHILE ON A PATIENT. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THIS EVENT. PATIENT WAS PUT ON ANOTHER VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483495 ↗
• MalfunctionDec 5, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR WAS FAILING THE EXHALATION TRANSDUCER CALIBRATION. IT WAS STATED THAT WHEN TRYING TO ZERO THE EXHALATION PRESSURE TRANSDUCER, THE AD READS 4000. THERE WAS NO PATIENT INVOLVED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916248 ↗
• MalfunctionNov 30, 2022Tactile Prompts/Feedback; Tactile Prompts/Feedback

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR TOUCHSCREEN LOCKED UP. AT THIS TIME, THER WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15891255 ↗
• MalfunctionSep 2, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR TRANSDUCER (XDCR) FAIL DURING OPERATIONAL VERIFICATION PROCEDURE (OVP). FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITHT THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353395 ↗
• MalfunctionAug 12, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS TRANSDUCER FAULT AND MOTOR FAULT ALARM. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222204 ↗
• MalfunctionJul 18, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR IS AUTO CYCLING. FURTHERMORE, THERE WAS NO PATIENT REPORTED ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048685 ↗
• MalfunctionJul 15, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR AUTO CYCLES 61BPM (BREATH PER MINUTE) WHEN SET AT 12BPM (BREATH PER MINUTE). THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15031176 ↗
• MalfunctionJun 8, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEMS WITH VELA VENTILATOR WHERE UNIT WAS ALARMING O2 RANGE ERROR DUE TO THE BLENDER OUTPUT BEING 8% OUT OF SPECIFICATIONS. AT THIS TIME, THERE WAS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640205 ↗
• MalfunctionMay 27, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR IS HAVING ISSUE WITH POWER AND THE SCREEN WAS FLICKERING. IT WAS DETERMINED THAT THE LCD CABLE NEEDED TO BE REPLACED BUT AFTER REPLACEMENT, THE MAIN DISPLAY REMAINS BLACK. WHEN UNIT IS TURNED ON, NO ALARMS ARE NOTED BUT THE FAN COMES ON. AND ON THE MAIN BOARD, ONLY ONE LED IS LIT, RATHER THAN 4. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14528868 ↗
• MalfunctionMay 23, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VENTILATOR INOPERABLE, MOTOR FAULT, LOW PEAK INSPIRATORY PRESSURE, LOW MINUTE VENTILATION AND HIGH RATE ALARMS ON THE VELA VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14478208 ↗