3100A HFOV 773997Recalls & reported problems
Carefusion Corporation · LONG PAT CKT, F&P850, BOX 4, 31A · Class 3
All models of 3100A HFOV (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20846446003373), received between Dec 18, 2018 and Feb 5, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Disconnection” (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
- Appropriate Device Problem Term/Code Not Available1
- Disconnection1
Patient problems
- Low Oxygen Saturation1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED A DEFECTIVE 3100A CIRCUIT, THE CUSTOMER EXPLAINED THAT WHEN THEY CONNECT THE CIRCUIT ON THE UNIT, THE HEATER ALARMED, THEY TRIED A NEW TEMP PORTS AND HUMIDIFIER BUT THE DEVICE STILL ALARMING. THE CUSTOMER REPLACED THE CIRCUIT AND SOLVED THE ISSUE. THE PROBLEM HAPPENED WHILE CONNECTED ON A PATIENT, HOWEVER, THE CUSTOMER ALSO CONFIRMED THAT THERE WAS NO HARM OR INJURY THAT WAS ASSOCIATED WITH THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9673498 ↗InjuryDec 18, 2018Disconnection; Disconnection
ADDITIONAL CUSTOMER INFORMATION RECEIVED ON 18DEC2018: THE CUSTOMER REPORTED THAT THE PATIENT WAS MANUALLY VENTILATED AND EXPERIENCED A LOW OXYGEN SATURATION DURING THIS EVENT.
Patient problems: Low Oxygen Saturation; No Known Impact Or Consequence To Patient
MAUDE report 8173434 ↗
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.
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