inforMED
MalfunctionIYT

INSTA/VENT

Received Oct 6, 2025 · Event occurred Sep 25, 2025

Report MW5176971 · MDR key 23224175

Device

Generic name

System, Rebreathing, Radionuclide

Lot number

25MN25265

Product problems

  • Gas Output Problem
  • Gas Output Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

KITS WERE FAILING THE SALINE TEST OR SIMPLY AEROSOLIZING POORLY. PT CODE: 4582. DEVICE CODE: 1266. REF REPORT: MW5176972.