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

Model Number	1020007
Medical Device Problem Codes	Overheating of Device (1437); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging no oxyge on a everflo device.There was no reported harm.The device was returned to the manufacturer's service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation, it was noted that the device had a burned pca and the device does not power on.The root cause is confirmed to be thermal damage of the pca.Additionally, during the service of the device, the manufacturer observed a dust-like contamination on the rear enclosure, scratches on the front enclosure, brown discoloration on the compressor inlet tube (indicative of tobacco use).Kinked/pinched cannula tube.Thermal damage on the pca (f3, t3) and blown fuse (f1) which is indicative of a voltage spike that occurred external to the device.Pil was unable to power on and test the device due to thermal damage on the pca.At this time, no further investigation can be performed.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 23036716
• Report Number: 2518422-2025-110091
• Device Sequence Number: 21210912
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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: 1020007
• Device Catalogue Number: 1020007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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