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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 ↗

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Sources and updates

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