Electronic Gas Blender 5 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04033817900702), received between Aug 1, 2017 and Oct 14, 2022 — classified as 5 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
- Appropriate Device Problem Term/Code Not Available1
- Device Displays Incorrect Message1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement2
- Low Oxygen Saturation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 14, 2022Gas Output Problem; Gas Output Problem
LIVANOVA RECEIVED REPORT THAT A S5 GAS BLENDER SYSTEM GAVE AN ERROR CODE ASSOCIATED TO A DISCREPANCY BETWEEN THE ACTUAL AND SET GAS FLOW VALUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15606073 ↗MalfunctionMar 7, 2022Gas Output Problem; Gas Output Problem
LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 GAS BLENDER SYSTEM GAVE A CALIBRATION ERROR AND ANOTHER ERROR ASSOCIATED TO A DISCREPANCY BETWEEN THE ACTUAL AND SET CO2 VALUE DURING A SERVICE ACTIVITY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13685038 ↗MalfunctionSep 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
LIVANOVA (B)(4) RECEIVED A REPORT THAT A S5 GAS BLENDER SYSTEM DISPLAYED AN ERROR MESSAGE DURING PROCEDURE. DUE TO THIS FAILURE A REDUCED BRAIN SATURATION WAS CAUSED WHICH WAS RECOVERED BY USING THE MECHANICAL BACKUP GAS BLENDER. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: Low Oxygen Saturation
MAUDE report 7876242 ↗MalfunctionOct 17, 2017No Flow; No Flow
LIVANOVA (B)(4) RECEIVED A REPORT THAT AN S5 GAS BLENDER SYSTEM HAD NO OXYGEN FLOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6956622 ↗MalfunctionAug 1, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
LIVANOVA (B)(4) RECEIVED A REPORT THAT S5 GAS BLENDER SYSTEM DISPLAYED AN ERROR MESSAGE AND THE S5 SYSTEM DISPLAYED AN "EXTERNAL DEVICE DEFECTIVE" MESSAGE DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6757142 ↗
Other Gas control unit, cardiopulmonary bypass devices
- Electronic Gas Blender 10 l/minLivaNova Deutschland GmbH · Gas control unit, cardiopulmonary bypass98 reports
- Quantum QVM2-D-HMSpectrum Medical Limited · Gas Control Unit, Cardiopulmonary Bypass36 reports
- 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 2 l/minLivaNova Deutschland GmbH · Gas control unit, cardiopulmonary bypass3 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.
How reports and recalls are matched · Editorial policy · Report an error on this page