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

Model Number	1020006
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	11/19/2025
Type of Reportable Event	Death
Event or Problem Description
This notification was reviewed due to a patient passing away on (b)(6) 2025; however, the death is unrelated as it was reported the injury did not result in permanent impairment to body function or permanent damage to body structure.The respiratory insufficiency was treated via hospitalization.The device was being used off label as the patient was prescribed 2l/min of oxygen while the in-home flowmeter would only deliver a maximum of 1l/min.If further information becomes available, an additional report will be filed.The manufacturer concludes no further action is needed at this time.
Additional Manufacturer Narrative
The manufacturer previously reported a patient passing away on (b)(6) 2025; however, the death is unrelated as it was reported the injury did not result in permanent impairment to body function or permanent damage to body structure.The respiratory insufficiency was treated via hospitalization.The device was being used off label as the patient was prescribed 2l/min of oxygen while the in-home flowmeter would only deliver a maximum of 1l/min.Correction includes box h: type of reported complaint updated to "death".

• 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: 24249053
• Report Number: 2518422-2026-003944
• Device Sequence Number: 9970333
• Product Code: CAW
• UDI-Device Identifier: 00606959032552
• UDI-Public: (01)00606959032552
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1020006
• Device Catalogue Number: 1020006
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2018
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR
• Patient Sex: Male