3100A HFOV 768901-RNTRecalls & reported problems
Carefusion Corporation · 3100A VENT, 115V, 60HZ, DOM RNT · Class 3
All models of 3100A HFOV (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a CareFusion 3100A high-frequency ventilator, a machine that breathes for patients who need it. The 55 reports mostly describe mechanical breakdowns — the unit shutting down or stopping while in use on a patient, pressure readings fluctuating, air leaking, and a damaged start/stop button — with 8 injuries and no deaths. Most reports mention no harm to the patient. No recalls name this device, and no reports were filed in the past 12 months.
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
- 55
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10846446005394), received between Aug 11, 2015 and Oct 27, 2023 — classified as 8 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (40 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 Problem40
- Pressure Problem6
- Leak/Splash3
- Infusion or Flow Problem2
- Calibration Problem1
- Component Missing1
- Erratic or Intermittent Display1
- Failure to Cycle1
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- No Patient Involvement4
- No Consequences Or Impact To Patient3
- No Information2
- Low Oxygen Saturation1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR HAS PRESSURE FLUCTUATIONS. 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 18017512 ↗MalfunctionOct 25, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE START/STOP BUTTON IS DAMAGED ON THE 3100 A VENTILATOR. CUSTOMER IS REQUESTING A DDI (DYNAMIC DISPLACEMENT INDICATOR) BOARD. FURTHERMORE, THERE WAS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18004172 ↗MalfunctionOct 12, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO THE (B)(6) MEDICAL THAT THE 3100 A VENT KEEPS STOPPING AND THE HERTZ WAS FLUCTUATING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17928274 ↗MalfunctionSep 25, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR 'STOPPED WHILE ON A PATIENT'. THERE WAS NO PATIENT HARM REPORTED FROM THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17814585 ↗MalfunctionSep 25, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR 'STOPPED WHILE ON A PATIENT'. THERE WAS NO PATIENT HARM REPORTED FROM THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17814581 ↗MalfunctionSep 25, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR 'STOPPED WHILE ON A PATIENT'. THERE WAS NO PATIENT HARM REPORTED FROM THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17814561 ↗MalfunctionSep 12, 2023Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED TO VYAIRE MEDICAL THAT UNIT SHUT DOWN WHILE ON A PATIENT ON THE 3100 A DEVICE. AT THIS TIME. THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17733676 ↗MalfunctionJun 29, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATOR'S MEAN AIRWAY PRESSURE (MAP) IS FLUCTUATING REALLY BAD DURING USE. THERE WAS NO KNOWN CONSEQUENCES OR IMPACT TO PATIENT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14863615 ↗MalfunctionJun 24, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MEAN AIRWAY PRESSURE (MAP) OF 3100A VENTILATOR IS FLUCTUATING WHILE ON PATIENT USE. AT THIS TIME, THERE WAS NO INFORMATION REGARDING PATIENT HARM AND INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14810390 ↗MalfunctionJun 24, 2022Pressure Problem; Pressure Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATOR IS NOT HOLDING PRESSURE. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED FROM THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14810126 ↗MalfunctionJun 23, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATOR HAD FLUCTUATING MEAN AIRWAY PRESSURE (MAP) WHILE ON PATIENT. THERE WAS NO KNOWN CONSEQUENCES OR IMPACT TO PATIENT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14794904 ↗MalfunctionJun 23, 2022Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED MINIMUM AIRWAY PRESSURE (PAW) ALARM IS STUCK ON REGARDLESS OF SETTINGS ON THE 3100 A VENTILATOR. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14794743 ↗MalfunctionJun 23, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATOR'S MAP IS OFF BY 30CMH2O. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14794729 ↗MalfunctionJun 22, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR STOPPED RUNNING WHILE ON PATIENT. AT THIS TIME, THERE WAS NO INFORMATION REGARDING PATIENT HARM AND INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14781828 ↗MalfunctionJun 22, 2022Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED MEAN AIRWAY PRESSURE FLUCTUATES DURING USE ON A PATIENT ON THE 3100 A DEVICE, THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14781823 ↗MalfunctionJun 22, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATORS THAT WHEN ADJUSTING THE LOWER LIMIT ALARM IT STARTS TO BEEP WHEN IT IS WITH IN 10 OF THE MAP ON THE VENT. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14781821 ↗MalfunctionJun 21, 2022Pressure Problem; Pressure Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATORS IS NOT CALIBRATING THE CORRECT PRESSURE. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14762023 ↗MalfunctionJun 21, 2022Pressure Problem; Pressure Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATORS IS NOT CALIBRATING THE CORRECT PRESSURE. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14761920 ↗MalfunctionJun 21, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATORS "DOES NOT HAVE DIAPHRAGM". AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14760679 ↗MalfunctionJun 21, 2022Pressure Problem; Pressure Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATORS IS NOT HOLDING PRESSURE. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14760600 ↗MalfunctionJun 17, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR FAILED ON THE PATIENT HAS LOUD HISSING NOISE AND UNIT STOPPED OSCILLATING. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14739622 ↗InjuryJun 16, 2022Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR MEAN AIRWAY PRESSURE (MAP) STARTED TO FLUCTUATE WHILE ON PATIENT USE. FURTHERMORE, THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR BUT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14722046 ↗MalfunctionMay 21, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100 A VENTILATOR DOES NOT PRESSURIZE ABOVE 5CM. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14466546 ↗MalfunctionFeb 18, 2022Pressure Problem; Pressure Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR IS NOT PRESSURIZING. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13561119 ↗MalfunctionJan 27, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR AIR PRESSURE COMING INTO THE UNIT IS LOW. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13366935 ↗
Other Ventilator, High Frequency devices
- 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) 768901Carefusion Corporation · Ventilator, High Frequency4 deaths587 reports
- 3100B HFOV 770155Carefusion Corporation · Ventilator, High Frequency1 death61 reports
- LifePort 2.5 mmBunnell, Incorporated · Ventilator, High Frequency1 recall0 reports
- Bunnell 903Bunnell, Incorporated · Ventilator, High Frequency1 recall0 reports
- 3100A HFOV 768901Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY30 reports
- 3100A HFOV 768901-RFBCarefusion Corporation · Ventilator, High Frequency18 reports
- 3100A HFOV 29028-011Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY9 reports
- 3100A HFOV 29028-004Vyaire Medical, Inc. · VENTILATOR, HIGH FREQUENCY6 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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