MAUDE Adverse Event Report: Respironics, Inc. EverFlo; Generator, Oxygen, Portable

Model Number	1020006
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging no flow and burning smell.The device settings during the event were reported to be unknown.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.Preliminary findings found that the clogged sieve caused the compressor to become overloaded and overheat, resulting in a burning smell.During the evaluation, the debug technician also noticed that the manifold was melted.Based on these findings, the sieves need to be replaced.Additionally, the inside of the rear cabinet is damaged, the whisper cap is cracked, and the capacitor is electrically defective.The inlet filter was replaced as part of preventive maintenance.The device was returned unrepaired to the manufacturer's product investigation lab (pil) for further investigation.

• 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: 50725444
• Report Number: 2518422-2026-045418
• Device Sequence Number: 10620863
• Product Code: CAW
• UDI-Device Identifier: 00606959032552
• UDI-Public: (01)00606959032552
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2023
• 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