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

Model Number	1020015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The manufacturer previously received information from a patient representative regarding an everflo device alleging the patient has passed away in a fire.The reported event is unclear as to an allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the harms reported.There are conflicting accounts of whether the device was in use at time of death.Therefore, based on the information currently provided and available, the device cause and/or contribution to the reported event cannot currently be confirmed.A report will be filed with all applicable regulatory agencies.The device has not yet been returned to the manufacturer for evaluation.Multiple good faith efforts have been made to obtain additional information, and the reporter has indicated the device will not be returning.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.
Event or Problem Description
The manufacturer received information from a patient representative regarding an everflo device alleging the patient has passed away in a fire.The reported event is unclear as to an allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the harms reported.There are conflicting accounts of whether the device was in use at time of death.Therefore, based on the information currently provided and available, the device cause and/or contribution to the reported event cannot currently be confirmed.A report will be filed with all applicable regulatory agencies.The device has not yet been returned to the manufacturer for evaluation.Multiple good faith efforts have been made to obtain additional information, and the reporter has indicated the device will not be returning.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.
Event or Problem Description
The manufacturer received information from a patient representative regarding an everflo device alleging the patient has passed away in a fire.The reported event is unclear as to an allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the harms reported.There are conflicting accounts of whether the device was in use at time of death.Therefore, based on the information currently provided and available, the device cause and/or contribution to the reported event cannot currently be confirmed.A report will be filed with all applicable regulatory agencies.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow-up report will be filed.

• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 24527919
• Report Number: 2518422-2026-008202
• Device Sequence Number: 8439663
• Product Code: CAW
• UDI-Device Identifier: 00606959032637
• UDI-Public: (01)00606959032637
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 1020015
• Device Catalogue Number: 1020015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2017
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown