VELA 16600 (UDI 10190752154230)Recalls & reported problems
Vyaire Medical, Inc. · VELA DIAMOND PACKAGE FOR KINDRED HEALTHCARE · Class 2
Quick summary
This VYAIRE VELA ventilator is a facility-use machine that delivers continuous breathing support. The 30 reports mostly describe calibration trouble, no output or no display, and low or missed breath volume, with the machine alarming or failing to cycle at times. Two injuries were reported and no deaths. No recalls name this device, and report numbers were the same in the last two 12-month periods.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10190752154230), received between Dec 30, 2021 and Oct 2, 2024 — classified as 2 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Failure to Calibrate” (9 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Calibrate9
- Failure to Recalibrate3
- No Device Output3
- No Display/Image3
- Failure to Deliver2
- Gas Output Problem2
- Low Readings2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2024Low Readings; Low Readings
IT WAS REPORTED TO VYAIRE MEDICAL THAT LOW VOLUME WHEN SET AT 500, BUT UNIT IS GIVING 227. UNKNOWN PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20352833 ↗MalfunctionOct 2, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA HAD PERSISTENT XDCR (TRANSDUCER) FAULT. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20352477 ↗MalfunctionSep 17, 2024Low Readings; Low Readings
IT WAS REPORTED TO VYAIRE MEDICAL LOW VTE AND LEAK. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20237937 ↗MalfunctionSep 13, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL THAT VENT INOP/MOTOR FAULT ALARMED, AND THE DEVICE WAS NOT VENTILATING. UNKNOWN PATIENT INVOLVEMENT
Patient problems: Insufficient Information
MAUDE report 20212904 ↗InjurySep 11, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENT HAD NO DISPLAY AND NOT VENTING. WHEN TURNING ON THE VENT, THE DISPLAY FLASHES ON THEN GOES BLACK. PATIENT INVOLVED. HOWEVER, NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20193057 ↗MalfunctionJul 9, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL: A MOTOR FAULT DEFECTIVE MOTOR BOARD WAS NOTED ON THE VELA VENTILATOR. CURRENTLY, PATIENT INVOLVEMENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19701273 ↗MalfunctionJun 20, 2024Gas Output Problem; Gas Output Problem
IT WAS REPORTED TO VYAIRE MEDICAL, THE CUSTOMER WAS UNABLE TO ACHIEVE SUFFICIENT RESPIRATORY VOLUME; ALTHOUGH THE TURBINE WAS RUNNING, THE RESPIRATORY VOLUME WAS TOO LOW. NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19578241 ↗MalfunctionJun 20, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL, THE CUSTOMER IS REQUESTING A PO FOR A MAIN BOARD AND TURBINE DUE TO TRANSDUCER FAULT CAUSING THE VELA VENTILATOR TO NOT CYCLE. ORDER WAS PROCESSED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19577090 ↗MalfunctionJun 20, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL, THE EXHALATION DIFF TRANSDUCER WAS FAILING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19577016 ↗MalfunctionJun 13, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL THAT ONSITE STAFF REPORTED MOTOR FAULT ALARM. CURRENTLY, NO PATIENT INVOLVEMENT WAS REPRORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19529167 ↗MalfunctionJun 13, 2024Failure to Recalibrate; Failure to Recalibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS AN ISSUE WITH THE VENTILATORS MAIN BOARD WHERE THE XDCR WAS FAILING CALIBRATION. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19527811 ↗MalfunctionJun 11, 2024Gas Output Problem; Gas Output Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR WAS EXPERIENCING A LOW INLET PRESSURE ISSUE. THE INITIAL REPORTER WAS INFORMED THAT THE REGULATOR NEEDS TO BE ADJUSTED OR REPLACED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509763 ↗MalfunctionMay 1, 2024Failure to Recalibrate; Failure to Recalibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR WAS ALARMING VENT INOPERABLE AND MOTOR FAULT ALARM. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19224724 ↗MalfunctionApr 29, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE THAT A TRANSDUCER FAULT OCCURRED. NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19209047 ↗MalfunctionApr 19, 2024Failure to Deliver; Failure to Deliver
IT WAS REPORTED TO VYAIRE MEDICAL THAT 'VENT INOP' ALARM AND MOTOR FAULT ENTRY ON ERROR LOG. DETERMINED FAILURE OF MAIN BOARD. NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19146722 ↗MalfunctionApr 18, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THE VENT IS NOT VENTILATING WHEN BOOTING UP AND REPLACED A NEW POWER SUPPLY WHICH DID NOT RECTIFY THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19139727 ↗MalfunctionApr 18, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT A NEW MAIN BOARD WAS ORDERED DUE TO CONSTANT XDCR FAULT CAUSING VENT NOT TO CYCLE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19133521 ↗MalfunctionApr 18, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT A NEW MAIN BOARD WAS ORDERED DUE TO CONSTANT XDCR FAULT CAUSING VENT NOT TO CYCLE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19133493 ↗MalfunctionApr 16, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL "TRANSDUCER FAULT". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19120764 ↗MalfunctionApr 16, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THE DISPLAY ON THE VELA VENTILATOR IS BLANK. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19116658 ↗MalfunctionApr 11, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT A TRANSDUCER FAULT (A0801 FAILURE TO CALIBRATE) OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19092251 ↗MalfunctionApr 11, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR PRODUCED A TRANSDUCER FAULT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19088419 ↗MalfunctionApr 10, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED TO VYAIRE THAT THE VELA CIRCUIT DISCONNECTED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19079809 ↗MalfunctionApr 2, 2024Power Problem; Power Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR INOP (INOPERABLE) ALARMED WHEN THE DEVICE WAS POWERED ON. A MOTOR FAULT ENTRY WAS FOUND ON THE ERROR LOG. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19024035 ↗MalfunctionApr 2, 2024Failure to Recalibrate; Failure to Recalibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENT CAME TO THE BIOMED SHOP AND IS ALARMING O2 SENSOR FAILURE CONSTANTLY. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19020434 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.