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

Model Number	1020007
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation of everflo intl opi that the patient alleges that the device has a defective power cord.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
The device was returned to a third-party service center.The technician confirmed there was no foam particles in the air path during the device evaluation.There were some secondary findings like power cord and silicone tube are damaged, sieves are clogged, inlet filter has to be replaced due to preventive maintenance.The device passed all test.In this report, box d, g, h has been updated/corrected.

• Brand Name: EVERFLO INTL OPI
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19485634
• Report Number: 2518422-2024-34087
• Device Sequence Number: 8139466
• Product Code: CAW
• UDI-Device Identifier: 00606959032569
• UDI-Public: 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2021
• 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