3100A HFOV 11518-850S (UDI 50190752155143)Recalls & reported problems
Vyaire Medical, Inc. · Flexible Patient Circuit w/Filter for 3100A (Box of 4) · Class 3
All models of 3100A HFOV (8)
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 50190752155143), received between Jun 14, 2022 and Jun 14, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Product Quality Problem” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Product Quality Problem1
Patient problems
- Hypoventilation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2022Product Quality Problem; Product Quality Problem
THE CUSTOMER REPORTED THAT A PATIENT WITH AML (ACUTE MYELOID LEUKEMIA) NEUTROPENIC SEPSIS AND PULMONARY EDEMA AND NEEDING 100% OXYGEN BUT MANAGING TO CLEAR CO2 (CARBON DIOXIDE) WAS PUT ON THE 3100A. HOWEVER, WHEN ON THE OSCILLATOR, PH DECREASED FROM 7.4 TO 6.8, AND C02 INCREASED FROM 6 TO 21. END USER PERFORMED HAND VENTILATION AND RETURNED THE PATIENT BACK ON THE 3100A WITH MAX MAP (MEAN AIRWAY PRESSURE) AND AMPLITUDE WITH NO IMPROVEMENT. FILTER HELPED SLIGHTLY. THE PATIENT WAS THEN TRANSFERRED TO HFOV B WHICH MANAGED WELL FOR 24 HOURS UNTIL THE BLUE FILTER BECAME REALLY WET AND COULD NOT MAINTAIN MAP. AS DESATURATION BEGAN, THE PATIENT WAS TRANSFERRED TO ANOTHER OSCILLATOR.
Patient problems: Hypoventilation
MAUDE report 14691335 ↗
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
- 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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