MAUDE Adverse Event Report: RESPIRONICS, INC. EverFlo; Generator, Oxygen, Portable

Model Number	1020000
Medical Device Problem Codes	Fire (1245); Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a patient experienced an explosion while using an everflo device.The device settings during the event were reported to are unknown.During the event, the patient's beard caught fire, and his nose, ears, and face were burned.The patient has not received medical intervention.The patient applied zinc ointment, and wounds are festering.Patient is also having trouble seeing and hearing.The everflo device has not yet been returned for evaluation.Additional information has been requested.

• Brand Name: EverFlo
• Common Device Name: Generator, Oxygen, Portable
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): Respironics, Inc.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; +1(724)733-0200
• MDR Report Key: 24687210
• Report Number: 2518422-2026-009981
• Device Sequence Number: 9855132
• Product Code: BZD
• UDI-Device Identifier: 00606959014954
• UDI-Public: 00606959014954
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown