inforMED
MalfunctionDTX

Electronic Gas Blender

Received Jul 30, 2026 · Event occurred Jul 3, 2026

Report 9611109-2026-90348 · MDR key 50085715

Device

Generic name

Gas Control Unit, Cardiopulmonary Bypass

Catalog number

25-40-45

Product problems

  • Gas Output Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

LivaNova Deutschland received a report that the Electronic Gas Blender (EGB) was not working. No air was reportedly coming from the device. The event was detected during procedure. There was no patient or user impact.

Additional Manufacturer Narrative

A.1.-A.5. Patient information was not provided. H11: LivaNova Deutschland manufactures the Electronic Gas Blender. The event occurred in Seattle, United StatesThrough follow-up communications, it was learned that when gas flow is increased, it fails to reach the set value and generates an alarm. The reported issue occurs intermittently and is resolved through power-cycling of the unit. Reportedly, the three status symbols are displayed when the issue occurs, indicating that the blender had apparently passed its internal checks.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.