3100 HFOV 10273Recalls & reported problems
Carefusion Corporation · KIT, BLENDER · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846446002317), received between Aug 11, 2020 and Dec 14, 2021 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem1
- Protective Measures Problem1
Patient problems
- No Information1
- Pneumothorax1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathDec 14, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE O2 (OXYGEN) BLENDER WAS NOT WORKING PROPERLY. INO (INHALED NITRIC OXIDE) WAS ADMINISTERED VIA INO DELIVERY DEVICE WITH HIGH FLOW OXYGEN BLENDER. THE BLENDER READ 100% HOWEVER THE ANALYZER READ 21%.THEY ATTEMPTED TO INCREASE OXYGENATION, THE INFANT SUSTAINED A PNEUMOTHORAX AND HEALTH DECLINED RAPIDLY AND THE PATIENT PASSED WITH PARENTS. THEY DISCOVERED THAT THE NUT RETAINING THE KNOB OF THE O2 BLENDER WAS LOOSE AND WAS NOT PROVIDING FRICTION FIT REQUIRED FOR ADJUSTMENT OF O2 CONCENTRATION. THE CUSTOMER CONFIRMED THAT THE HEALTH CARE PROVIDER ATTEMPTED TO INCREASE OXYGENATION. HOWEVER, THE INFANT'S HEALTH SUSTAINED PNEUMOTHORAX. INFANT'S HEALTH DECLINING RAPIDLY AND PASSED WITH PARENTS.
Patient problems: Pneumothorax
MAUDE report 13006341 ↗MalfunctionAug 11, 2020Protective Measures Problem; Protective Measures Problem
THE CUSTOMER REPORTED THAT THE BLENDER EXPERIENCED GAS DIFFERENTIAL ALARM. THE BLENDER WAS USED AT 50 TO 55 LPM. IT STARTED ALARMING AT ABOUT 35 TO 40 PSI. IT IS THE SAME ALARM IF ONE OF THE GAS SOURCES IS LOW OR THE DIFFERENCE IN PRESSURE IS 20 PSI OR GREATER. AT THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT.
Patient problems: No Information
MAUDE report 10394140 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page