inforMED
MalfunctionCAX

MEDICAL GAS FLOWMETER REGULATOR

Received Mar 7, 2023 · Event occurred Feb 2, 2023

Report 1526809-2023-00001 · MDR key 16494986

Device

Generic name

Flowmeter Regulator

Model number

M1-540-15FM

Catalog number

M1-540-15FM

Product problems

  • Material Rupture
  • Use of Device Problem

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

AN ADULTERATED MEDICAL GAS FLOWMETER RUPTURED DURING A NONMEDICAL APPLICATION OF THE DEVICE USED OUTSIDE THE SPECIFIED TEMPERATURE RANGE.