InjuryCAN

DRIVE DEVILBISS HEALTHCARE

Received Jul 24, 2024 · Event occurred Oct 10, 2021

Report 2438477-2024-00040 · MDR key 19818545

Device

Generic name

Regulator, Pressure, Gas Cylinder

Manufacturer

Danyang Airtech Co., Ltd

Model number

18302GMN

Catalog number

18302GMN

Product problems

Use of Device Problem
Use of Device Problem

Patient

NA · Female

Full thickness (Third Degree) Burn
Full thickness (Third Degree) Burn

Narrative

Description of Event or Problem

DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A REGULATOR BY A LETTER FROM AN ATTORNEY, WHICH STATES THE END USER WAS REFILLING AN OXYGEN TANK ON WHICH THE REGULATOR WAS PLACED, WHEN LEAKING OXYGEN CAUSED A FIRE TO TEMPORARILY IGNITE AND THE END USER TO SUSTAIN 3RD DEGREE BURNS TO HER LEFT HAND. DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT THROUGH PARTICIPATION IN A LAWSUIT. NO SPECIFIC DEFECT IN THE REGULATOR HAS BEEN IDENTIFIED. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.