Vmax 777405-101Recalls & reported problems
Carefusion Corporation · VMAX ENCORE 22D · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846446021417), received between Jun 19, 2019 and Mar 31, 2021 — classified as 1 injury, 2 malfunctions.
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 16, 2026.
Most reported problems
Device problems
- Mechanical Problem1
- Patient Device Interaction Problem1
- Smoking1
Patient problems
- Injury1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2021Smoking; Smoking
IT IS REPORTED TO VYAIRE MEDICAL THAT THE VMAX ENCORE 22 EXPERIENCED A BURNING SMELL UPON INSTALLATION OF SAMPLE PUMP. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11599994 ↗MalfunctionOct 15, 2020Mechanical Problem; Mechanical Problem
A CUSTOMER CONTACTED VYAIRE MEDICAL TO REPORT THAT THEY NOTED THE FAN INSIDE THE DELL PC WAS, "WHINING AND SMELLED HOT." UPON REPLACING THE PC, THEY STARTED GETTING GAS NOT CONNECTED WARNINGS EVEN THOUGH THEY WERE CONNECTED TO THE WALL O2. CUSTOMER WAS ADVISED TO PUT THE PC BACK TO THE ORIGINAL SYSTEM, AND REPLACE THE SOL CABLE FROM THE SYSTEM IN ORDER TO RESOLVE THE COMMUNICATION PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 10686886 ↗InjuryJun 19, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
WHILE USING THE VMAX FOR PULMONARY FUNCTION TESTING, THE PATIENT'S LIPS WERE STICKING TO THE MOUTHPIECE AND CAUSING THEIR LIPS TO BLEED.
Patient problems: Injury
MAUDE report 8713841 ↗
Other Calculator, Predicted Values, Pulmonary Function devices
- Vmax 777404-101Carefusion Corporation · Calculator, Predicted Values, Pulmonary Function4 reports
- Vyaire V-171466-13Jaeger Medical GmbH · Calculator, Predicted Values, Pulmonary Function3 reports
- Vyaire V-707254Jaeger Medical GmbH · Calculator, Predicted Values, Pulmonary Function2 reports
- VMAX 777404-101Vyaire Medical, Inc. · CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION1 report
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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