MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO120V OPI DOMESTIC; GENERATOR, OXYGEN, PORTABLE

Model Number	1020001
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The everflo device was sent to a third-party service center for investigation.During evaluation, the third-party service center found the device had melted covers, and it was found that the foam above the exhaust port came unglued and blocked the exhaust which caused overheating, melting the covers.Additionally, unrelated to the reportable malfunction, the device was alarming and exhibited blown sieves and low purity of 49%.The technician was able to duplicate problem due to case full of sieve dust; faulty compressor specs of 17 lpm@20 psi, causing low purity and alarming.A final report will be sent once the investigation is concluded.
Additional Manufacturer Narrative
Pr has been corrected since the device has been evaluated by the third-party service center; appropriate coding has been added to reflect the issue.

• Brand Name: EVERFLO120V OPI DOMESTIC
• 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: 24575645
• Report Number: 2518422-2026-009370
• Device Sequence Number: 18449977
• Product Code: CAW
• UDI-Device Identifier: 00606959022041
• UDI-Public: (01)00606959022041
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: Other
• Device Model Number: 1020001
• Device Catalogue Number: 1020001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2021
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown