MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO 120V; GENERATOR, OXYGEN, PORTABLE

Model Number	1020001
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from a third-party service center work order which alleged a burnt pc (printed circuit) board and blown sieve occurred on an everflo 120v opi.There was no death, serious harm or injury, and no medical intervention was reported.The device has not yet been returned for evaluation.If the device is returned and evaluated, a follow-up report will be submitted with the evaluation results.
Event or Problem Description
The everflo device was sent to a third-party service center for evaluation.The work order indicated that a burnt printed circuit board and blown sieve beds were found in the device.The device was not reported to be in clinical use at the time of the incident.There was no death, serious harm or injury, and no medical intervention was reported.
Additional Manufacturer Narrative
This report is being submitted to correct the b5 statement and update related fields.

• Brand Name: EVERFLO 120V
• 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: 23424224
• Report Number: 2518422-2025-111415
• Device Sequence Number: 13168322
• Product Code: CAW
• UDI-Device Identifier: 00606959022041
• UDI-Public: (01)00606959022041
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: Other
• Device Model Number: 1020001
• Device Catalogue Number: 1020001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2021
• 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