3100A HFOV 768901Recalls & reported problems
Vyaire Medical, Inc. · 3100A OSCILLATORY VENTILATOR · Class 3
All models of 3100A HFOV (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Vyaire 3100A high-frequency oscillatory ventilator is a breathing machine used in hospitals. The 30 reports mostly describe the unit failing to power on or start, shutting down, or losing pressure and flow, along with burnt smells, odd noises, and water in the tubing. There are 3 injuries and no deaths, and no recalls name this device. Reports dropped sharply, from 18 in the earlier 12 months to 1 in the most recent 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
- 30
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10190752155329), received between Jan 25, 2023 and Nov 4, 2025 — classified as 3 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (6 reports).
1 other recall cover devices cleared under the same FDA submission (P890057); they may or may not involve this specific model.
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
- Improper Flow or Infusion6
- Mechanical Problem6
- Device Emits Odor4
- No Device Output3
- Unexpected Shutdown3
- Pressure Problem2
- Smoking2
- Activation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BEFORE USE, THE DEVICE WAS EXPERIENCING O2 LEAKAGE FAILURE AND THE LOCKING TAB ON POWER KNOB IS NON-FUNCTIONAL. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23467100 ↗MalfunctionOct 23, 2025Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE DRIVER WOULD NOT START. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368263 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE VENTILATOR HAD WATER IN THE GREEN TUBING. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301788 ↗MalfunctionOct 15, 2025Device Emits Odor; Smoking; Device Emits Odor; Smoking
IT WAS REPORTED THAT THE DEVICE HAS BEEN PLUGGED AND HAS ELECTRICAL BURNS AND SMELL. THERE IS NO PHYSICAL DAMAGE NOR BURN MARKS ON THE UNIT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 23285266 ↗MalfunctionOct 15, 2025Device Emits Odor; Smoking; Device Emits Odor; Smoking
IT WAS REPORTED THAT A BURNT SMELL WAS OBSERVED COMING FROM THE DEVICE WHILE BEING USED ON A PATIENT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285084 ↗MalfunctionOct 6, 2025Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THE VENT IS NOT WORKING WHILE ON A PATIENT AND IS LOSING PRESSURE WHEN DROPPING BELOW 10CM H20. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23227614 ↗MalfunctionOct 6, 2025No Device Output; No Device Output
THE CUSTOMER REPORTED THAT THE UNIT WILL BE PRESSURIZED BUT FAILS TO START. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23227589 ↗MalfunctionOct 6, 2025Pressure Problem; Pressure Problem
IT WAS REPORTED THAT UPON SET UP, THE PISTON CENTERING DISPLAY COULD NOT BE SEEN AND THE MAP WOULD NOT HOLD PRESSURE ON THE DEVICE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23227537 ↗MalfunctionOct 3, 2025Failure to Cycle; Failure to Cycle
IT WAS REPORTED THAT THE DRIVER ON THE DEVICE STOPPED WORKING TWICE WHILE BEING USED ON A PATIENT. ANOTHER DEVICE WAS USED. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23210006 ↗MalfunctionSep 29, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE POWER AMPLITUDE DISPLAY OF THE DEVICE IS NOT WORKING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23166492 ↗MalfunctionSep 25, 2025Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE VENTILATOR WILL NOT PRESSURIZE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23145683 ↗MalfunctionSep 9, 2025Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT BEFORE USE, THERE WAS A BURNING SMELL WHEN THE DEVICE WAS POWERED ON. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004672 ↗MalfunctionAug 26, 2025Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE'S PISTON WOULDN'T START AND FAILED TO CYCLE/OSCILLATE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 22893847 ↗MalfunctionAug 26, 2025Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE'S PISTON WOULDN'T START AND FAILED TO CYCLE/OSCILLATE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 22893825 ↗MalfunctionAug 26, 2025Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE'S PISTON WOULDN'T START AND FAILED TO CYCLE/OSCILLATE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 22893645 ↗MalfunctionJul 10, 2025Improper Flow or Infusion; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE HAD A LOW DELTA P READING. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 22468200 ↗MalfunctionJul 2, 2025Improper Flow or Infusion; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE'S MAP (MEAN AIRWAY PRESSURE) WAS FLUCTUATING. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382474 ↗MalfunctionApr 28, 2025Mechanical Problem; Improper Flow or Infusion; Mechanical Problem; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE STOPPED RUNNING. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21921070 ↗MalfunctionApr 21, 2025Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING USE ON A PATIENT, THE DEVICE SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874473 ↗MalfunctionOct 22, 2024Activation Failure; Activation Failure
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DRIVER DOES NOT ACTIVATE. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20506992 ↗MalfunctionOct 14, 2024Device Emits Odor; Device Emits Odor
IT WAS REPORTED TO VYAIRE MEDICAL THAT END USER SMELLED RUBBER BURNING DURING USE. UNKNOWN PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20441253 ↗InjurySep 24, 2024No Device Output; No Device Output
ADDITIONAL INFORMATION RECEIVED INDICATES THAT A COMPANY FIELD SERVICE ENGINEER WAS SENT OUT TO CUSTOMER SITE FOR ON-SITE REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20293087 ↗InjurySep 18, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED TO VYAIRE MEDICAL THAT WHILE ON A PATIENT THE VENT SHUT DOWN AND RESTARTED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20252027 ↗InjurySep 5, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE UNIT STOPPED WORKING WHILE ON PATIENT. UNIT WAS OVERDUE FOR 2K PM. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20153017 ↗MalfunctionJul 24, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED TO VYAIRE MEDICAL THAT A CHIRPING NOISE WHEN THE UNIT IS OSCILLATING. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19819501 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P890057. One submission often covers many models, so check the product and lot details in each record.
- Z-0488-2024 · Oct 27, 2023 · Completedvyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
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
- 3100A HFOV 768901-RNTCarefusion Corporation · Ventilator, High Frequency55 reports
- LifePort 2.5 mmBunnell, Incorporated · Ventilator, High Frequency1 recall0 reports
- Bunnell 903Bunnell, Incorporated · Ventilator, High Frequency1 recall0 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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