3100A HFOV 771374Recalls & reported problems
Carefusion Corporation · FLEX CKT 38IN HTD WIRE F&P 730 BX 4 · Class 3
All models of 3100A HFOV (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20846446003380), received between Feb 2, 2021 and Feb 2, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Circuit Failure” (1 report).
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.
Most reported problems
Device problems
- Circuit Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2021Circuit Failure; Circuit Failure
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 771374 771374 FLEX CKT 38IN HTD WIRE F&P 730 BX 4, HEATED CIRCUITS WITH THE (B)(4) STOPPED WORKING. THERE WAS A PATIENT INVOLVED IN THIS REPORTED EVENT, HOWEVER, NO HARM WAS NOTED AS THEY WERE ABLE TO REMOVE THE PATIENT FROM THE VENTILATOR AND BAGGED THE PATIENT TO REPLACE THE CIRCUIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11269909 ↗
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 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page