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

Model Number	1020000
Medical Device Problem Codes	Fire (1245); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information related to an everflo portable oxygen concentrator.The device was returned to a third party service center.The service technician alleges external fire damage, thermal event to patient tubing, customer unsure if device caused fire.Then the evaluation shows that the fire was external, all evidence indicative of patient use/originating external to unit design.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was sent to a third party service center for evaluation.During evaluation, a burnt humidifier base cable was found.The third party service center was unable to complete the investigation, and the device will be forwarded to the manufacturer product investigation laboratory and investigated further.
Additional Manufacturer Narrative
The manufacturer previously reported information related to an everflo portable oxygen concentrator.The device was returned to a third party service center.The service technician alleges external fire damage, thermal event to patient tubing, customer unsure if device caused fire.Then the evaluation shows that the fire was external, all evidence indicative of patient use/originating external to unit design.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was sent to a third party service center for evaluation.During evaluation, a burnt humidifier base cable was found.The third party service center was unable to complete the investigation, and the device will be forwarded to the manufacturer product investigation laboratory and investigated further.Correction: evaluation method code.

• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 22212773
• Report Number: 2518422-2025-106657
• Device Sequence Number: 8619875
• Product Code: CAW
• UDI-Device Identifier: 00606959014954
• UDI-Public: (01)00606959014954
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: Other
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2020
• 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
• Patient Sex: Unknown