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

Model Number	1020008
Medical Device Problem Codes	Device Emits Odor (1425); Overheating of Device (1437); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was notified that an everflo oxygen concentrator failed to power on and emitted a burning smell.Upon reviewing the reported event, it was unclear if there was any thermal damage to the pca.There was no confirmation or statement that the device showed any signs of physical thermal damage.The device was subsequently sent to a third-party service center for evaluation.Upon inspection, the service center identified several issues: the integrated canister was clogged, the inlet filter was replaced as part of preventive maintenance, the pca was defective, the capacitor showed signs of electrical failure, both the front and rear cabinets were damaged, the spring kit was rusty, and the compressor was malfunctioning.Additionally, the evaluation revealed additional failure of a "burning capacitor." the unit will be sent to the product investigation lab for further analysis.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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: 21775437
• Report Number: 2518422-2025-103715
• Device Sequence Number: 15472146
• Product Code: CAW
• UDI-Device Identifier: 00606959032576
• UDI-Public: (01)00606959032576
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2026

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: 1020008
• Device Catalogue Number: 1020008
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 06/29/2026; 07/09/2026
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 06/30/2026; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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