Electronic Gas Blender 10 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
Quick summary
This LivaNova electronic gas blender controls the gas mix used in heart bypass surgery. Its 101 FDA reports include no deaths and no injuries, and mostly describe gas output problems, such as the blend dropping below set values, with some reports of alarms and incorrect readings. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 98
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 04033817900696), received between Aug 1, 2016 and Sep 28, 2026 — classified as 97 malfunctions.
The most frequently reported specific device problem is “Gas Output Problem” (63 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.
Reports received per month
Most reported problems
Device problems
- Gas Output Problem63
- Incorrect, Inadequate or Imprecise Result or Readings6
- Device Displays Incorrect Message5
- Appropriate Device Problem Term/Code Not Available3
- Improper Flow or Infusion3
- Inaccurate Flow Rate3
- Device Operational Issue2
- Device Sensing Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions79
- No Patient Involvement11
- No Consequences Or Impact To Patient8
Recent adverse event reports
The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Gas Output Problem
LivaNova Deutschland received a report of an Electronic Gas Blender (EGB) for which an error message was displayed and could not operate properly. The event occurred during priming.There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912093 ↗MalfunctionSep 28, 2026Power Problem
LivaNova Deutschland received a report of an Electronic Gas Blender (EGB) which suddenly stopped working during priming and could not operate. Cold start and unplugging/re-plugging of unit's cables did not resolve the issue. Consequently, device was replaced with a new one.There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911823 ↗MalfunctionSep 28, 2026Gas Output Problem
LivaNova Deutschland received a report of an Electronic Gas Blender (EGB) for which an error message was displayed and device could not operate properly. The event occurred during procedure.There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911736 ↗MalfunctionSep 2, 2026Gas Output Problem
See initial report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565110 ↗MalfunctionApr 30, 2026Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ELECTRONIC GAS BLENDER (EGB) ACCURACY WAS OUTSIDE THE MEASUREMENT RANGE. THE EVENT WAS DETECTED DURING MAINTENANCE INSPECTION. THERE WAS NO PATIENT OR USER IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045504 ↗MalfunctionMar 26, 2026Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ELECTRONIC GAS BLENDER (EGB) SHOWED FLOW OF 0,3 L/MIN DESPITE THE SET VALUE OF 0 L/MIN. AFTER RESTARTING IT, THE EGB WORKED AS EXPECTED. REPORTEDLY, THE ISSUE OCCURRED MULTIPLE TIMES, BUT IT IS NOT ALWAYS REPRODUCIBLE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700309 ↗MalfunctionMar 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT CONCERNING AN ELECTRONIC GAS BLENDER (EGB) DELIVERING A FLOW RATE THAT DIFFERED FROM THE VALUE SHOWN ON THE DEVICE DISPLAY. THE CUSTOMER INDICATED THAT NO ERROR CODES WERE GENERATED; ONLY THE DELIVERED FLOW DID NOT CORRESPOND TO THE DISPLAYED FLOW RATE. THE ISSUE WAS REPORTEDLY OBSERVED DURING A PROCEDURE. NO PATIENT IMPACT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24555871 ↗MalfunctionDec 19, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE S5 HLM ELECTRONIC GAS BLENDER SHOWED ERROR 19 DURING PRIMING. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23848141 ↗MalfunctionDec 17, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE ELECTRONIC GAS BLENDER WAS NOT WORKING PROPERLY AND DISPLAYED ERROR CODE 1000. THE ISSUE OCCURRED DURING INSTALLATION. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826293 ↗MalfunctionDec 12, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT ABOUT AN ERROR CONCERNING THE S5 HLM GAS BLENDER. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23787383 ↗MalfunctionNov 21, 2025Gas Output Problem; Gas Output Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617827 ↗MalfunctionNov 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605562 ↗MalfunctionNov 13, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ELECTRONIC GAS BLENDER WHICH DISPLAYED ERROR MESSAGE ONTO DISPLAY (E19, "CALIBRATION FAULT"). THE EVENT OCCURRED DURING REGULAR MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543976 ↗MalfunctionNov 7, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND RECEIVED REPORT OF AN ELECTRONIC GAS BLENDER (EGB) THAT WAS NOT WORKING PROPERLY. THE ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498448 ↗MalfunctionOct 31, 2025Gas Output Problem; Gas Output Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433960 ↗MalfunctionOct 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF OUT-OF-SPECIFICATION FIO2 READING ON THE ELECTRONIC GAS BLENDER. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379126 ↗MalfunctionOct 24, 2025Gas Output Problem; Gas Output Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23376795 ↗MalfunctionOct 23, 2025Output Problem; Output Problem
LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ELECTRONIC GAS BLENDER (EGB) WHICH SPORADICALLY SHOWED ERROR MESSAGE (E15, "FAULT IN AD TRANSFORMER"). THE ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368951 ↗MalfunctionOct 17, 2025Gas Output Problem; Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
LIVANOVA RECEIVED A REPORT OF AN ESSENZ COCKPIT WHICH FROZE DURING PROCEDURE. REPORTEDLY, THE ELECTRONIC GAS BLENDER SHUT OFF AS CONSEQUENCE OF COCKPIT FREEZING. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23325428 ↗MalfunctionSep 17, 2025Output Problem; Unexpected Shutdown; Output Problem; Unexpected Shutdown
LIVANOVA DEUTSCHLAND RECEIVED A REPORT OF AN ISSUE DURING USAGE OF THE ELECTRONIC GAS BLENDER. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073368 ↗MalfunctionAug 27, 2025Gas Output Problem; Gas Output Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903206 ↗MalfunctionJul 30, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT, DURING SERVICE, THE ELECTRONIC GAS BLENDER DISPLAYED ALARM E19 (CALIBRATION FAULT, A FAULT HAS OCCURRED IN THE ACTUAL VALUE/ACTUAL VALUE COMPARISON. SENSOR ACTUAL VALUE). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666498 ↗MalfunctionJul 30, 2025Unexpected Shutdown; Unexpected Shutdown
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, DURING PROCEDURE, WHEN THE FIO2 SETTINGS WERE ADJUSTED ON THE S5 SYSTEM DISPLAY, ELECTRONIC GAS BLENDER SUDDENLY LOST POWER. AN ALARM FOR MODULE FAILURE OCCURRED, THEREFORE THE AFFECTED UNIT WAS TURNED ON AND USED AGAIN, AFTER WHICH THE SURGERY ENDED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664743 ↗MalfunctionJul 24, 2025Gas Output Problem; Gas Output Problem
LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT, DURING PRIMING, THE ELECTRONIC GAS BLENDER DISPLAYED ALARM E19 (CALIBRATION FAULT) AND MODULE DEFECTIVE ERROR MESSAGE APPEARED IN THE MACHINE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22585059 ↗MalfunctionMay 28, 2025Gas Output Problem; Gas Output Problem
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095376 ↗
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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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