inforMED
MalfunctionCAD

TEC

Received Jul 28, 2026 · Event occurred Jul 1, 2026

Report 2112667-2026-04743 · MDR key 50057931

Device

Generic name

Vaporizer

Manufacturer

Datex-ohmeda, Inc.

Model number

850 SEV

Catalog number

NA

Lot number

NA

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

It was reported that there was a malfunction resulting in insufficient agent delivery less that -20% of setting. There was no patient injury.

Additional Manufacturer Narrative

A GE Healthcare¿s investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed.No repair information available.Block A: Patient information could not be obtained due to country privacy laws.Legal Manufacturer:HCS Madison - 3030 Ohmeda Dr, USA Madison, WI 53718