3100A HFOV 11518-850LRecalls & reported problems
Carefusion Corporation · BOXED PATIENT CIRCUIT ASSY, 31A, FILTERED, 850L · Class 3
All models of 3100A HFOV (7)
Data updated Oct 18, 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 10846446003185), received between Jul 4, 2020 and Jul 4, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Component” (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 18, 2026.
Most reported problems
Device problems
- Defective Component1
Patient problems
- Respiratory Failure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 4, 2020Defective Component; Defective Component
THE CUSTOMER REPORTED THAT A PATIENT WAS BEING VENTILATED WITH AN MAP OF 14 CM/H20. HOWEVER, WITHIN 12 HOURS, THE MAP SPIKED TO 20 CM/H2O AND COULD NOT BE REDUCED BY THE ADJUSTMENT DIAL. UPON CHECKING, THE BOXED PATIENT CIRCUIT ASSY, 31A, FILTERED, 850L WAS SATURATED. ONCE IT WAS REMOVED, THE MAP RETURNED TO NORMAL. IT WAS LATER INDICATED THAT THE PATIENT DECOMPENSATED AND HAD TO BE DISCONNECTED FROM THE HFOV AND MANUALLY VENTILATED. CHEST X-RAY REVEALED RIGHT MIDDLE LOBE COLLAPSE AND LEFT-SIDED DIAPHRAGMATIC HERNIA.
Patient problems: Respiratory Failure
MAUDE report 10230993 ↗
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
- Bunnell 903Bunnell, Incorporated · Ventilator, High Frequency1 recall0 reports
- LifePort 2.5 mmBunnell, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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