3100A HFOV 773996Recalls & reported problems
Carefusion Corporation · SHORT 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20846446003397), received between Apr 8, 2019 and Mar 10, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
- Mechanical Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED THAT THE CIRCUIT 3100A IS TOO LOOSE. AS AN INTERVENTION, THEY TAPE THE UP THE LOOSE PART. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9813167 ↗MalfunctionApr 8, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE 3100A VENTILATOR EXPERIENCED AN ISSUE WITH THE MEAN AIRWAY PRESSURE (MAP) JUMPING ALL OVER THE PLACE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Patient Involvement
MAUDE report 8493606 ↗
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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