Electronic Gas Blender 2 l/minRecalls & reported problems
LivaNova Deutschland GmbH · Class 2
All models of Electronic Gas Blender (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04033817900719), received between Aug 23, 2022 and Jun 20, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Gas Output Problem” (2 reports).
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
- Gas Output Problem2
- Device Sensing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2023Gas Output Problem; Gas Output Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17160879 ↗MalfunctionApr 17, 2023Device Sensing Problem; Device Sensing Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16750550 ↗MalfunctionAug 23, 2022Gas Output Problem; Gas Output Problem
LIVANOVA RECEIVED REPORT THAT DURING A PROCEDURE A S5 GAS BLENDER SYSTEM ALARMED AND AFTER SOME SECONDS THE GAS FLOW STOPPED. THE PERFUSIONIST CHANGED TO MECHANICAL GAS BLENDER TO CONTINUE THE PROCEDURE. AFTER THE PROCEDURE, THE PERFUSIONIST TRIED TO START AGAIN THE DEVICE AND IT COULD NOT BE TURNED ON. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15275720 ↗
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- Quantum QVM4-D-HMSpectrum Medical Limited · Gas Control Unit, Cardiopulmonary Bypass18 reports
- Quantum QVM2-N-HMSpectrum Medical Limited · Gas Control Unit, Cardiopulmonary Bypass11 reports
- Quantum QVMSpectrum Medical Limited · Gas Control Unit, Cardiopulmonary Bypass10 reports
- Quantum QLS1-200Spectrum Medical Limited · Gas Control Unit, Cardiopulmonary Bypass8 reports
- Electronic Gas Blender 5 l/minLivaNova Deutschland GmbH · Gas control unit, cardiopulmonary bypass5 reports
- Quantum QLS1-120Spectrum Medical Limited · Gas Control Unit, Cardiopulmonary Bypass2 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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