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

Model Number	1020010
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation of everflo device stating unit sparked and damaged the wall socket.It did not trip the main power box.Upon inspection in the workshop, one ac power has signs of burning and corrosion with melting visible on the surrounding plastic.The tech arrived onsite and reported that is melted the plug head and damaged the wall socket.They are concerned as it didn't trip the main powerbox, for which could be a house issue.Unit has been replaced.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation.Should any additional information be received, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported that the manufacturer became aware of an allegation for an everflo device stating the unit sparked and damaged the wall socket.It did not trip the main power box.Upon inspection in the workshop, one ac power has signs of burning and corrosion with melting visible on the surrounding plastic.The tech arrived onsite and reported that it melted the plug head and damaged the wall socket.They are concerned as it didn't trip the main powerbox, for which could be a house issue.Unit has been replaced.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Updated: box h: device manufacturers: evaluation method code updated.Evaluation results code updated.Component code updated.Conclusion code updated.

• 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: 23399259
• Report Number: 2518422-2025-111373
• Device Sequence Number: 10084289
• Product Code: CAW
• UDI-Device Identifier: 00606959001077
• UDI-Public: (01)00606959001077
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: 1020010
• Device Catalogue Number: 1020010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown