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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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Sources and updates

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