TIMETER OXYGEN FLOWMETER
Received Dec 10, 2024 · Event occurred Jun 22, 2023
Report 1924066-2024-00130 · MDR key 20888602
Device
Generic name
Oxygen Flowmeter
Manufacturer
Allied Healthcare Products Inc.Model number
15001-03Catalog 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