inforMED
DeathCAX

TIMETER OXYGEN FLOWMETER

Received Dec 10, 2024 · Event occurred Jun 22, 2023

Report 1924066-2024-00130 · MDR key 20888602

Device

Generic name

Oxygen Flowmeter

Model number

15001-03

Catalog number

15001-03

Lot number

N/A

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

NA · Unknown

  • Hypoxia
  • Hypoxia

Narrative

Description of Event or Problem

IT WAS REPORTED : THE CUSTOMER ATTACHED A NITROUS OXIDE ADAPTER TO THE INLET OF THE OXYGEN FLOWMETER. THE FLOWMETER WITH THE N2O ADAPTER WAS ATTACHED TO A NITROUS OXIDE OUTLET STATION AND TURNED ON. THE PATIENT WAS GIVEN 100% NITROUS OXIDE AND DIED.

Additional Manufacturer Narrative

THIS FLOWMETER WAS ORDERED AND SOLD WITHOUT AN INLET ADAPETER, BECAUSE SOME FOREIGN COUNTRIES NEED SPECIFIC ADAPTERS TO BE COMPATIBLE WITH THE OUTLET STATIONS THEY USE IN THEIR COUNTRIES. THE INSTRUCTIONS SHEET THAT IS SHIPPED IWH TEACH FLOWMETERS STATES "DO NOT MIX GASES". THIS FLOWMETER WAS LABELD AND COLOR CODED FOR USE IWTH OXYGEN. NO WHERE WAS THERE ANY INDICATION IT WAS OK TO USE IT WITH NITOUS OXIDE. CUSTOMER MODIFIED THE FLOWMETER AND DID NOT VERIFY MODIFICATION WAS CORRECT BEFORE USE.

Remedial action

  • Notification
  • Other