3100B HFOV 770155 (UDI 10190752158627)Recalls & reported problems
Vyaire Medical, Inc. · 3100B VENT ASSY, DOMESTIC · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752158627), received between Jul 16, 2024 and Oct 24, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Battery 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Battery Problem1
- Decrease in Pressure1
- High Readings1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025No Flow; No Flow
COMPLAINANT REPORTED THAT THE VENT DOES NOT OSCILLATE. COMPLAINANT DID NOT INDICATE ANY ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23380235 ↗MalfunctionOct 15, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT WHILE TREATING A PATIENT, THE DEVICE'S MAP DROPPED. ADVERSE EFFECT TO THE PATIENT WAS NOT INDICATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23291109 ↗MalfunctionAug 12, 2024Battery Problem; Battery Problem
IT WAS REPORTED TO VYAIRE MEDICAL: NO ALARM SOUNDING, BATTERY IS CURRENTLY MEASURED AT 10.35V AND THE DISPLAY IS BLANK. WE ARE UNABLE TO SEE IF THERE IS AN E20 OR 21 ERROR CODE, SINCE THE DISPLAY IS BLANK. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19960892 ↗MalfunctionJul 16, 2024High Readings; High Readings
IT WAS REPORTED TO VYAIRE MEDICAL: THE RESPIRATORY THERAPISTS REPORTED FLUCTUATING MAP AND DELTA P WHILE ON PATIENT. PATIENT HARM OR INJURY WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19751128 ↗
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
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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