Vela 16600 (UDI 10846446001358)Recalls & reported problems
Carefusion Corporation · VELA DIAMOND PACKAGE FOR KINDRED HEALTHCARE · Class 2
All models of VELA (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This CareFusion Vela ventilator has 1,225 adverse event reports, including 4 deaths and 141 injuries. Most reports describe mechanical problems, and others describe display faults, output problems, or calibration issues. Some narratives mention transducer faults and alarms such as circuit disconnect and oxygen range errors. 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
- 1,225
- Deaths reported
- 4
- Injuries reported
- 141
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,225 adverse event reports that list this exact device (DI 10846446001358), received between Oct 31, 2018 and Jun 17, 2024 — classified as 4 deaths, 141 injuries, 1,080 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (934 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
- Mechanical Problem934
- Output Problem49
- Display or Visual Feedback Problem48
- Calibration Problem24
- No Display/Image23
- Leak/Splash15
- Erratic or Intermittent Display12
- Infusion or Flow Problem9
Patient problems
- No Clinical Signs, Symptoms or Conditions642
- No Patient Involvement369
- No Consequences Or Impact To Patient124
- No Information65
- No Known Impact Or Consequence To Patient13
- Insufficient Information5
- Low Oxygen Saturation4
- Death3
Recent adverse event reports
The 25 most recent of 1,225 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2024Failure to Recalibrate; Failure to Recalibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT A CIRCUIT DISCONNECT ALARM OCCURRED. NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19551704 ↗MalfunctionJun 12, 2024Low Readings; Low Readings
IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING A PREVENTATIVE MAINTENANCE CHECK THE TECHNICIAN REPLACED THE BLENDER AND FOUND THAT THE FIO2 WAS NOT IN SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19524134 ↗MalfunctionJun 7, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR HAD A PROBLEM WITH THE EXHALATION FLOW TRANSDUCER FAULT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484887 ↗MalfunctionJun 6, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THEY RECEIVED PO FOR NEW MAIN BOARD DUE TO PERSISTENT XDCR FAULT PROCESSED ORDER. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19480413 ↗InjuryMay 16, 2024Low Readings; Low Readings
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA REPORTED LOW VTE WHILE UNIT WAS ON PATIENT. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19333247 ↗InjuryMay 13, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MAIN BOARD FOR DEVICE ALARMED TRANSDUCER FAULT. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19306106 ↗MalfunctionMay 1, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENT HAD PERSISTENT XDCR FAULT CAUSING VENT NOT TO CYCLE. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19222500 ↗MalfunctionApr 29, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT AN O2 RANGE ERROR ALARM OCCURRED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19202585 ↗MalfunctionApr 22, 2024Low Readings; Low Readings
IT WAS REPORTED TO VYAIRE MEDICAL A PERSISTENT TRANSDUCER FAULT OCCURRED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159748 ↗MalfunctionApr 15, 2024Failure to Charge; Failure to Charge
IT WAS REPORTED TO VYAIRE THAT THE BATTERY IS NOT CHARGING THE LUNG WAS NOT INFLATING. NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19110187 ↗MalfunctionApr 9, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AC AND DC LEDS NO LONGER ILLUMINATE. THERE WAS NO LED DURING NORMAL USE OR LAMP TEST. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19072812 ↗MalfunctionApr 9, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAS NO DISPLAY. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19070625 ↗MalfunctionApr 8, 2024Display Difficult to Read; Display Difficult to Read
IT WAS REPORTED TO VYAIRE THAT THE VELA TOUCH SCREEN IS NOT WORKING. NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19061828 ↗MalfunctionApr 4, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL A TRANSDUCER FAULT OCCURRED DURING MAINTENANCE WORK. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19044438 ↗MalfunctionApr 2, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL THE VELA VENTILATOR SHOWED THE ALARM XDCR (TRANSDUCER) FAIL. THE TRANSDUCER CALIBRATIONS WERE PERFORMED BUT THEY DID NOT PASS. NO PATIENT WAS INVOLVED ON THIS FAILURE, IT HAPPENED WHEN DURING OVP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19021582 ↗MalfunctionApr 1, 2024Display Difficult to Read; No Tactile Prompts/Feedback; Display Difficult to Read; No Tactile Prompts/Feedback
IT WAS REPORTED TO VYAIRE THAT THE SCREEN WAS DIMMED AND UNRESPONSIVE. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: Insufficient Information
MAUDE report 19015106 ↗MalfunctionMar 26, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THE VELA DIAMOND'S VENTILATOR SCREEN DOES NOT TURN ON WHEN THE VENT IS POWERED ON. BUT IT IS CYCLING NORMALLY WHICH INDICATES THE DISPLAY IS DEFECTIVE, HE REQUESTED THE PN FOR THE FRONT PANEL. END USER DISCOVERED ISSUE, NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18978729 ↗MalfunctionMar 26, 2024Failure to Conduct; Failure to Conduct
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR IS HAVING A TRANSDUCER FAULT DURING USER VERIFICATION TESTS (UVT). FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18977648 ↗MalfunctionMar 21, 2024Failure to Conduct; Failure to Conduct
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATORS XDCR FAULT ALARM PERSISTED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18949145 ↗MalfunctionMar 20, 2024Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED TO VYAIRE THAT THE VELA HAD A LOW TIDAL VOLUME AND THE CIRCUIT DISCONNECTED. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18941958 ↗MalfunctionMar 20, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT XDUCR FAULT OCCURRED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18941796 ↗MalfunctionMar 15, 2024Smoking; Smoking
IT WAS REPORTED TO VYAIRE MEDICAL A COMPLAINT OF SMOKE COMING FROM VENTILATOR. INSIDE FOUND BURNED AREAS AROUND TURBINE TUBING, MOTOR BOARD, BLENDER CABLES AND BOARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18911768 ↗MalfunctionMar 15, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED TO VYAIRE MEDICAL THE UNIT IS AUTO CYCLING SINCE LAST YEAR. NO PATIENTS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18911745 ↗MalfunctionMar 14, 2024Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED TO VYAIRE THAT THE VENT WAS DELIVERING TOO MUCH VOLUME. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909006 ↗MalfunctionMar 12, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL THAT A XDCR (TRANSDUCER) FAULT OCCURRED DURING A MAINTENANCE WORK. CUSTOMER STATES THE SUSPECT DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18889232 ↗
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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