VELA 16531-12Recalls & reported problems
Vyaire Medical, Inc. · VELA PLUS INT CF,DISS,GRN O2,TYPE K,ICON OVERLAY · Class 2
All models of VELA (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752153349), received between Jan 4, 2023 and Jun 17, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Calibrate” (2 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.
Reports received per month
Most reported problems
Device problems
- Failure to Calibrate2
- Failure to Recalibrate1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT A "TRANSDUCER FAULT". OCCURRED WITH THE VELA VENTILATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19548118 ↗MalfunctionJun 17, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL A "TRANSDUCER FAULT." OCCURRED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19548069 ↗MalfunctionApr 4, 2024Failure to Recalibrate; Failure to Recalibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AIRWAY PRESSURE DID NOT INCREASE DURING A MAINTENANCE WORK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19041625 ↗InjuryJan 4, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS VENT INOP (INOPERABLE) WHILE ON A PATIENT. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THIS EVENT. THE PATIENT WAS MOVED TO ANOTHER VENTILATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16095697 ↗
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
- 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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