VELA 16530-00 (UDI 10846446001600)Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 10846446001600), received between Nov 2, 2018 and Apr 18, 2024 — classified as 41 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (98 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 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2024No Device Output; No Device Output

  IT WAS REPORTED TO VYAIRE MEDICAL THE VELA VENTILATOR PRESENTED WITH A VENT INOP ALARM. ALARM OCCURRED DURING SETUP. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139592 ↗
• MalfunctionDec 21, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAD A MOTOR FAULT ALARM. FURTHERMORE, THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375399 ↗
• MalfunctionOct 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR IS FAILING LEAK TEST. ADDITIONALLY, THE UNIT INFLATES THE LUNG BUT READS 0.0 FOR THE RESULT. FURTHERMORE, THERE WAS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17969451 ↗
• MalfunctionJul 28, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A LOW TIDAL VOLUME ON THE VELA VENTILATOR WAS BEING 250 WHILE SET AT 400 PRIOR TO PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17411143 ↗
• MalfunctionMar 2, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS VENT INOP, MOTOR FAULT, LOW PIP(PEAK INSPIRATORY PRESSURE), HIGH PIP(PEAK INSPIRATORY PRESSURE) AND TRANSDUCER FAULT ALARMS TRIGGERED WHEN UNIT WAS POWERED ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16473061 ↗
• MalfunctionJan 24, 2023Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237244 ↗
• InjuryOct 18, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT TRANSDUCER FAULT ALARM OCCURRED DURING USE ON A PATIENT ON THE VELA VENTILATOR. THE CUSTOMER REPORTED THE PATIENT WAS PUT ON A DIFFERENT VENTILATOR. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629310 ↗
• MalfunctionOct 18, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT TRANSDUCER FAULT, LOW PEAK INSPIRATORY PRESSURE, AND LOW MINUTE VENTILATION ALARMS OCCURRED 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 15629262 ↗
• InjuryOct 15, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT VENTILATOR INOPERABLE, MOTOR FAULT, LOW PEAK INSPIRATORY PRESSURE, LOW MINUTE VENTILATION AND HIGH RATE ALARMS OCCURRED DURING USE ON A PATIENT ON THE VELA VENTILATOR. THE CUSTOMER REPORTED THE PATIENT WAS PUT ON A DIFFERENT VENTILATOR. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612409 ↗
• MalfunctionAug 30, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAD EXPERIENCED LOW O2 INLET PRESSURE . THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325361 ↗
• MalfunctionAug 24, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR ALARMED VENT INOP (VENTILATOR INOPERABLE). THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15289090 ↗
• MalfunctionMay 24, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VENTILATOR INOPERABLE AND MOTOR FAULT ALARMS DURING USE ON A PATIENT ON THE VELA VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492693 ↗
• InjuryMay 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR ALARMED "XDCR FAULT (TRANSDUCER FAULT), LOW PIP (POSITIVE INSPIRATORY PRESSURE) AND LOW VE (VENTILATION) WHILE ON A PATIENT. THE PATIENT WAS TRANSFERRED TO 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 14478803 ↗
• MalfunctionMay 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR ALARMED TRANSDUCER FAULT. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14478458 ↗
• InjuryMar 20, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT WHILE THE VELA VENTILATOR WAS RUNNING, "HIGH PIP" (PEAK INSPIRATORY PRESSURE), "LOW PIP", "HIGH PEEP" (POSITIVE END-EXPIRATORY PRESSURE), "HIGH RATE" AND "XDCR FAULT" (TRANSDUCER FAULT) ALARMS OCCURRED. THE ISSUE OCCURRED DURING PATIENT-USE AND 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 13831802 ↗
• InjuryFeb 10, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR ALARMED VENT INOP (VENTILATOR INOPERABLE), MOTOR FAULT, XDCR FAULT (TRANSDUCER FAULT) AND LOW PIP (PEAK INSPIRATORY PRESSURE) WHILE ON A PATIENT. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13507078 ↗
• InjuryFeb 10, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT VENT INOPERABLE, MOTOR FAULT, TRANSDUCER FAULT, LOW VE (LOW MINUTE VENTILATION), AND LOW PIP (PEAK INSPIRATORY PRESSURE) ALARMS OCCURRED ON VELA VENTILATOR. THE ISSUE OCCURRED DURING PATIENT-USE AND 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 13506985 ↗
• InjuryJan 6, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TRANSDUCER FAULT, HIGH RATE, HIGH PEAK INSPIRATORY PRESSURE AND LOW MINUTE VENTILATION ALARMS TRIGGERED DURING USE ON A PATIENT ON THE VELA VENTILATOR. THE CUSTOMER REPORTED THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178401 ↗
• MalfunctionNov 3, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR WAS READING TRANSDUCER FAULT. 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 12746237 ↗
• MalfunctionOct 13, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT VELA VENTILATOR UNIT IMMEDIATELY WHEN WAS POWERED ON, HIGH RATE, HIGH PIP/PEAK INSPIRATORY PRESSURE, LOW VE/MINUTE VENTILATION AND XDCR/TRANSDUCER FAULT ALARMS TRIGGERED. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12626235 ↗
• InjurySep 23, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED HIGH PEAK INSPIRATORY PRESSURE AND APNEA INTERVAL ALARMS DURING USE ON A PATIENT ON THE VELA VENTILATOR. THE ISSUE OCCURRED DURING PATIENT-USE AND 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 12522394 ↗
• MalfunctionSep 14, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR UNIT HAS XDCR FAULT/TRANSDUCER ALARM. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471278 ↗
• MalfunctionSep 14, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS CIRCUIT OCCLUSION WHEN POWERED ON. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471135 ↗
• MalfunctionAug 11, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED CIRCUIT DISCONNECT AND LOW PEAK INSPIRATORY PRESSURE DURING USE ON A PATIENT ON THE VELA VENTILATOR. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306575 ↗
• InjuryAug 3, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TRANSDUCER FAULT ALARM WHILE ON A PATIENT ON THE VELA VENTILATOR. THE CUSTOMER REPORTED THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268384 ↗