MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO; GENERATOR, OXYGEN, PORTABLE

Model Number	1020006
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information regarding an everflo device following an allegation of burning smell and smoke.Additionally, it was noted that the device did not alarm, would not power on, and did not display hours.No visible burn marks were found on the cable, plug, or the device itself.A technical evaluation performed by the repair shop determined that the main board was faulty.No adverse consequences to the patient were reported.There was no allegation of serious or permanent harm or injury, and the patient did not report receiving any medical intervention.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow-up report will be submitted.

• 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 ; 7247330200
• MDR Report Key: 25437667
• Report Number: 2518422-2026-020080
• Device Sequence Number: 10321921
• Product Code: CAW
• UDI-Device Identifier: 00606959032552
• UDI-Public: (01)00606959032552
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1020006
• Device Catalogue Number: 1020006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 06/09/2026; 06/01/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/09/2026; 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown