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

Model Number	1020007
Medical Device Problem Codes	Device Emits Odor (1425); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A device was returned to a third-party service center for service.There was no report of serious patient harm or injury.There was no report of medical intervention.Customer complaint alarm and smells charred was confirmed.During the evaluation of the device, they found canister assy, o2 pilot solenoid worn, flowmeter cracked, manifold assy, overlay kit and braided silicone tube damaged.The device was repaired.Reportable since device issue/event has or may have caused or contributed to a death.
Additional Manufacturer Narrative
The manufacturer previously reported that a device was returned to a third-party service center for service.There was no report of serious patient harm or injury.There was no report of medical intervention.Customer complaint alarm and smells charred was confirmed.During the evaluation of the device, they found canister assembly, o2 pilot solenoid worn, flowmeter cracked, manifold assembly, overlay kit and braided silicone tube damaged.The device was repaired.Reportable since device issue/event has or may have caused or contributed to a death.After further review, this issue was incorrectly reported and will now be considered a non-reportable issue.Correction to the event description is as follows: the manufacturer received information alleging alarm red after 5 minutes, smells charred.There was no patient harm or injury associated with this notification, no increased risk to the intended user and no medical intervention reported.There was no report of flames, smoking, burning, melting, or warping.During the evaluation of the device at the third-party service center, the customer complaint was not able to be confirmed.There was no information of any thermal findings, during the evaluation of the device.The canister assembly, o2 pilot solenoid, flowmeter, manifold assembly, overlay kit and braided silicone tube were replaced for preventative maintenance alone.This device meets ul and iec requirements for flammability.The everflo oxygen concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy.The device is not intended to be life supporting or life sustaining.Based on the available information, there is not enough evidence to indicate this issue is reportable to any regulatory agencies.No report will be filed with any regulatory agencies at this time.

• 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: 22041045
• Report Number: 2518422-2025-105792
• Device Sequence Number: 12986481
• Product Code: CAW
• UDI-Device Identifier: 00606959032569
• UDI-Public: (01)00606959032569
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: Lay User/Patient
• Device Model Number: 1020007
• Device Catalogue Number: 1020007
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/17/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2020
• 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