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

Model Number	1020000
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the patient had smelled something burning and the nurses took the device off before it caught fire.There is no allegation of serious or permanent harm or injury.No medical intervention was specified as required by the patient.The manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A supplemental follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported that the manufacturer received information alleging the patient had smelled something burning and the nurses took the device off before it caught fire.There is no allegation of serious or permanent harm or injury.No medical intervention was specified as required by the patient.The manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.The product associated with this complaint was not returned to the manufacturer.This report is being sent to conclude that no further investigation is possible.No device has been returned.No further evaluation is possible at this time.Multiple attempts to have the device returned for evaluation and investigation were unsuccessful.In addition, capa pr 7211 documents the investigation into similar complaints, correction/removal activities have been initiated (refer to h.9), and complaint code trending is reviewed on a periodic basis to evaluate field quality performance, and as an input to risk management activities.Section product udi in box d, box h has been updated/corrected in this report.

• 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: 20502089
• Report Number: 2518422-2024-102394
• Device Sequence Number: 8402285
• Product Code: CAW
• UDI-Device Identifier: 00606959022041
• UDI-Public: (01)00606959022041
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: Lay User/Patient
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2019
• 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