VELA 16532-00 (UDI 10846446001419)Recalls & reported problems
Carefusion Corporation · VELA CF COMP,DISS,GRN O2,TYPE K,ENG · Class 2
Quick summary
This Carefusion VELA ventilator is the subject of 1,033 adverse event reports, which mention 2 deaths and 196 injuries. Most reports describe mechanical problems, such as motor and transducer faults, and others describe gas leaks, display problems and calibration problems. No recalls name this device.
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
- 1,033
- Deaths reported
- 2
- Injuries reported
- 196
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,033 adverse event reports that list this exact device (DI 10846446001419), received between Oct 29, 2018 and Jun 5, 2024 — classified as 2 deaths, 196 injuries, 835 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (797 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
- Mechanical Problem797
- Display or Visual Feedback Problem41
- Output Problem34
- Calibration Problem22
- Leak/Splash19
- No Display/Image10
- Device Displays Incorrect Message9
- No Tactile Prompts/Feedback8
Patient problems
- No Clinical Signs, Symptoms or Conditions710
- No Patient Involvement188
- No Consequences Or Impact To Patient76
- No Information37
- No Known Impact Or Consequence To Patient12
- Low Oxygen Saturation5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Cardiopulmonary Arrest1
Recent adverse event reports
The 25 most recent of 1,033 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2024Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED TO VYAIRE MEDICAL THAT A LOW O2 INLET ERROR WAS OBSERVED. NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19469265 ↗MalfunctionMay 20, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT A XDCR FAULT AND AUTO-CYCLE OCCURRED WITH THE VELA VENTILATOR. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355466 ↗MalfunctionMay 6, 2024Gas Output Problem; Gas Output Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT AN O2 LEAK SOUNDED. NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19255336 ↗MalfunctionMay 2, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED TO VYAIRE MEDICAL A HIGH PPEEK AT 40 TRIGGERS A CIRCUIT OCCLUSION ALARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19231911 ↗MalfunctionApr 30, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE IS AN AUDIBLE LEAK COMING FROM SAFETY VALVE ON THE BLENDER ASSEMBLY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19212086 ↗MalfunctionApr 26, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT BIOMED CALLED REQUESTING ONSITE SERVICE FOR MOTOR FAULT ALARM. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19193498 ↗MalfunctionApr 25, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING PREVENTATIVE MAINTENANCE THE VELA VENT HAS XDCR MOTOR FAULT, LOW PIP AND LOW VTE. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19186000 ↗MalfunctionMar 13, 2024Intermittent Continuity; Intermittent Continuity
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR AD AN XDCR FAULT, MOTOR FAULT, HW FAULT, POST DAC AND ADC ERROR DURING EXTENDED SYSTEMS TEST (EST)/USER VERIFICATION TESTS (UVT). FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18895022 ↗MalfunctionMar 12, 2024Tidal Volume Fluctuations; Tidal Volume Fluctuations
IT WAS REPORTED TO VYAIRE MEDICAL REQUESTING A FIELD SERVICE ENGINEER (FSE) TO EVALUATE THE VELA VENTILATOR DUE TO THE VENTILATOR READING 0ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18890672 ↗InjuryMar 11, 2024Low Readings; Low Readings
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAD A LOW TIDAL VOLUMES. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS SWAPPED OUT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18875026 ↗MalfunctionMar 8, 2024Failure to Conduct; Failure to Conduct
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS TRANSDUCER FAULT OCCURRED (1,0,1311) EX FLOW TRANSDUCER. FURTHERMORE THERE WAAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865866 ↗MalfunctionMar 5, 2024No Tactile Prompts/Feedback; No Tactile Prompts/Feedback
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR TOUCH SCREEN DOES NOT RESPOND TO TOUCHES TO MODIFY SETTINGS. AS PER THE CUSTOMER, THE EVENT HAPPENED DURING EST(EXTENDED SYSTEMS TEST). FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18837602 ↗MalfunctionFeb 23, 2024Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED TO VYAIRE MEDICAL THAT LOW O2 INLET ALARM 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 18767962 ↗MalfunctionFeb 13, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS NO DISPLAY. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18696442 ↗MalfunctionFeb 1, 2024Defective Component; Defective Component
IT WAS REPORTED TO VYAIRE MEDICAL THAT MOTOR FAULT 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 18623085 ↗MalfunctionJan 31, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR SCREEN IS FLICKERING. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619738 ↗MalfunctionJan 31, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR DISPLAY IS NOT WORKING ON THIS UNIT, IT'S BLACK. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18617448 ↗MalfunctionJan 31, 2024Defective Component; Defective Component
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR IS ALARMING AN O2 INLET LOW. THERE WAS NO PATIENT HARM REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18614540 ↗MalfunctionJan 30, 2024No Tactile Prompts/Feedback; No Tactile Prompts/Feedback
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR TOUCH SCREEN NOT WORKING. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18611141 ↗MalfunctionJan 29, 2024Defective Component; Defective Component
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR IS ALARMING AN O2 INLET LOW. THERE WAS NO PATIENT HARM REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18603146 ↗MalfunctionJan 26, 2024Activation Failure; Activation Failure
IT WAS REPORTED TO VYAIRE MEDICAL THAT HIGH POSITIVE END EXPIRATORY PRESSURE, MOTOR FAULT AND VENTILATOR INOPERABLE ALARMS OCCURRED ON THE VELA VENTILATOR. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18589682 ↗MalfunctionJan 25, 2024Defective Component; Defective Component
IT WAS REPORTED TO VYAIRE MEDICAL THAT MOTOR FAULT 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 18585016 ↗MalfunctionJan 25, 2024Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR MOTOR FAULT ALARM. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18584802 ↗MalfunctionJan 20, 2024Calibration Problem; Calibration Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT TRANSDUCER FAULT ALARM 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 18548942 ↗MalfunctionJan 14, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR DC STATUS LED DID NOT LIGHT UP WHEN THE VENT WAS POWERED ON. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18509725 ↗
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.