VELA 16532-00 (UDI 10190752153325)Recalls & reported problems
Vyaire Medical, Inc. · VELA CF COMP,DISS,GRN O2,TYPE K,ENG OVERLAY · Class 2
All models of VELA (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10190752153325), received between Jan 27, 2022 and Jun 14, 2024 — classified as 3 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Failure to Calibrate” (3 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 Calibrate3
- No Device Output3
- Failure to Recalibrate2
- Mechanical Problem2
- Display or Visual Feedback Problem1
- Failure to Conduct1
- Gas/Air Leak1
- High Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2024No Device Output; No Device Output
ADDITIONAL INFORMATION RECEIVED INDICATES THAT A VYAIRE MEDICAL FSE WAS ABLE TO GO TO CUSTOMER SITE AND RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19537559 ↗MalfunctionJun 13, 2024Failure to Conduct; Failure to Conduct
IT WAS REPORTED TO VYAIRE MEDICAL: CUSTOMER TRIED TO CALIBRATE THE TRANSDUCERS WITH ONE FAILING. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19531794 ↗MalfunctionJun 12, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENT IS GIVING CONSTANT XDCR FAULT AFTER CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19518493 ↗InjuryJun 11, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR WENT INOPERABLE WHILE ON A PATIENT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510217 ↗MalfunctionJun 5, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED TO VYAIRE MEDICAL THAT INTERNAL LEAKING SOUND IS HEARD. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19472307 ↗InjuryJun 5, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENT WENT INOP. WHILE TRANSPORTING PATIENT WITHIN HOSPITAL. THEY WERE ABLE TO BAG THE PATIENT SO NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19472044 ↗MalfunctionMay 9, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL A XDCR FAULT APPEARED ON THE VELA VENTILATOR DEVICE BY END USERS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19280133 ↗MalfunctionApr 22, 2024Failure to Recalibrate; Failure to Recalibrate
IT WAS REPORTED TO VYAIRE THAT TRANSDUCER FAULT OCCURRED WITH THE VELA VENTILATOR. FURTHERMORE, THE RESPIRATORY RATE WAS INCORRECT. THE EVENT OCCURRED DURING SETUP WITH NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19152293 ↗MalfunctionApr 18, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELAS TOUCH SCREEN IS NOT WORKING. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19137465 ↗MalfunctionApr 16, 2024Failure to Recalibrate; Failure to Recalibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA HAD MOTOR FAULT, COIN CELL BATT ALARMS AND FAILING PM¿S. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19122036 ↗MalfunctionMar 27, 2024High Readings; High Readings
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR WHEN PERFORMING THE BLENDER FIO2 (FRACTION OF INSPIRED OXYGEN) CALIBRATION IS GETTING VALUES OVER 100% AND CANNOT ADJUST PERMANENTLY DOWNWARD. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18986112 ↗MalfunctionJun 16, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS A PROBLEM REGARDING DC (DIRECT CURRENT) INDICATOR LED (LIGHT-EMITTING DIODE) THAT IS DIM. FURTHERMORE, THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17145000 ↗InjuryJan 30, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS TRANSDUCER FAULT DURING PATIENT USE. THERE IS NO PATIENT HARM REPORTED. PATIENT WAS PLACED ON ANOTHER VENTILATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16268537 ↗MalfunctionJan 27, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR IS PRESENTING WITH OXYGEN RANGE ERROR. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13367091 ↗
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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