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

Model Number	1020006
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to a everflo device.There was an allegation of broken cable.There was no report of patient harm or injury.There was no report of medical intervention.The device was returned to a third-party service center for evaluation.During evaluation, the technician observed that the power cord was burnt.Upon review of the event, the service center has been instructed to return the device to the manufacturer product investigation laboratory (pil) for further investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.

• Brand Name: EVERFLO
• Common Device Name: OXYGEN CONCENTRATOR
• 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: 24663417
• Report Number: 2518422-2026-009869
• Device Sequence Number: 5042240
• Product Code: CAW
• UDI-Device Identifier: 00606959032552
• UDI-Public: (01)00606959032552
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Foreign,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: Other
• 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: 03/19/2026
• Initial Report FDA Received Date: 03/23/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown