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

Model Number	18302GDEL
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/11/2022
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving an oxygen regulator involved in an ignition event by a letter from an attorney, which alleges that the resulting fire was caused by an alleged defect in the regulator.The fire resulted in property damage.Although a death was reported, the medical examiner did not attribute the death to the device.Drive is currently investigating the incident, and will file an update 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: 18016213
• Report Number: 2438477-2023-00137
• Device Sequence Number: 6539130
• Product Code: CAN
• UDI-Device Identifier: 00822383143170
• UDI-Public: 00822383143170
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/26/2023
• Report Date (Section F): 10/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 18302GDEL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/27/2023
• Event Location: Home
• Date Report to Manufacturer: 10/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2023
• 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: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/26/2023