inforMED
InjuryBSZ

DIGITAL ULTRA FLUSHMOUNT PACKAGE H

Received Nov 21, 2025 · Event occurred Sep 8, 2025

Report 2020813-2025-00010 · MDR key 23620054

Device

Generic name

Flowmeter And Scavanging Circuit

Manufacturer

Accutron, Inc.

Model number

56800

Catalog number

56800

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

NA · Unknown

  • Vomiting
  • Vomiting

Narrative

Additional Manufacturer Narrative

A COMPLETE AND THOROUGH TEST AND EVALUATION WAS CONDUCTED OF DEVICE IN AS RECEIVED CONDITION AND COULD NOT DUPLICATE REPORTED PROBLEM. DEVICE MEETS FACTORY SPECIFICATIONS.

Description of Event or Problem

DISTRIBUTOR REPORTED PATIENTS GETTING SICK ON N2O. TWO PATIENTS VOMITED MID-TREATMENT ON DIFFERENT DAYS IN THIS SAME ROOM.