MAUDE Adverse Event Report: DANYANG AIRTECH CO., LTD DRIVE DEVILBISS HEALTHCARE; REGULATOR, PRESSURE, GAS CYLINDER

Model Number	18302GMN
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): DANYANG AIRTECH CO., LTD; plant 2, no. 17; dandong indusry park; zhenjiang, jiangsu ; CH
• MDR Report Key: 19818545
• Report Number: 2438477-2024-00040
• Device Sequence Number: 21003636
• Product Code: CAN
• UDI-Device Identifier: 00822383283210
• UDI-Public: 00822383283210
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2024
• Report Date (Section F): 07/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 18302GMN
• Device Catalogue Number: 18302GMN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/29/2023
• Event Location: Home
• Date Report to Manufacturer: 07/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 07/24/2024