MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO DOM NON- OPI 120V US/CAN; GENERATOR, OXYGEN, PORTABLE

Model Number	1020000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received a voluntary medwatch (b)(4).The manufacturer received information from the patient alleging 2nd degree burns to his face right of nose, right upper lip, and bilateral nostrils.The patient lit a cigarette while oxygen was in use.The instruction for use warning states, "do not smoke, allow others to smoke, or have open flames near the concentrator when it is in use.Smoking during oxygen therapy is dangerous and is likely to result in facial burns or death." no other medical information or interventions were reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Added voluntary medwatch mdr number (b)(4) in the corresponding block in section h10 per request from fda dated (b)(6) 2025.
Event or Problem Description
The manufacturer received a voluntary medwatch (b)(4).The manufacturer received information from the patient alleging 2nd degree burns to his face right of nose, right upper lip, and bilateral nostrils.The patient lit a cigarette while oxygen was in use.The instruction for use warning states, "do not smoke, allow others to smoke, or have open flames near the concentrator when it is in use.Smoking during oxygen therapy is dangerous and is likely to result in facial burns or death." no other medical information or interventions were reported.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: EVERFLO DOM NON- OPI 120V US/CAN
• 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 ; 7247330200
• MDR Report Key: 22012234
• Report Number: 2518422-2025-105551
• Device Sequence Number: 17478419
• Product Code: CAW
• UDI-Device Identifier: 00606959014954
• UDI-Public: (01)00606959014954
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: Not provided; 05/06/2026
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/22/2025; 03/11/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown