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

Model Number	1020000
Medical Device Problem Codes	Fire (1245); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	11/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received a voluntary medwatch (120535-2024-0001) in reference to an everflo oxygen concentrator.The user was smoking in bed while using the everflo oxygen concentrator on (b)(6) 2024, resulting in ignition (unspecified fuel source).The patent's granddaughter was reported to have smothered the fire with a blanket.The following day the patient's homecare nurse assessed the patient noting right upper thigh and nasal burns (reported 2nd degree).Further medical evaluation via ems was declined and the patient was reported to have received triple antibiotic ointment for the wounds.The device has not been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously received a voluntary medwatch (120535-2024-0001) in reference to an everflo oxygen concentrator.The user was smoking in bed while using the everflo oxygen concentrator on (b)(6) 2024, resulting in ignition (unspecified fuel source).The patent's granddaughter was reported to have smothered the fire with a blanket.The following day the patient's homecare nurse assessed the patient noting right upper thigh and nasal burns (reported 2nd degree).Further medical evaluation via ems was declined and the patient was reported to have received triple antibiotic ointment for the wounds.The manufacturer previously submitted mdr 2518422-2024-105504 stating voluntary medwatch, 120535-2024-0001, was received in reference to an everflo concentrator.The manufacturer did not include this related report number in h10 on the previous report.The manufacturer is submitting a correction to include voluntary medwatch 120535-2024-0001 in h10.Section h10 has been updated in this report.
Additional Manufacturer Narrative
The manufacturer previously received a voluntary medwatch (b)(4) in reference to an everflo oxygen concentrator.The user was smoking in bed while using the everflo oxygen concentrator on (b)(6) 2024, resulting in ignition (unspecified fuel source).The patent's granddaughter was reported to have smothered the fire with a blanket.The following day the patient's homecare nurse assessed the patient noting right upper thigh and nasal burns (reported 2nd degree).Further medical evaluation via ems was declined and the patient was reported to have received triple antibiotic ointment for the wounds.Despite three good faith effort attempts, the device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be completed.If any additional information is received at a later date, a supplemental report will be filed.The reported failure of thermal issue is accommodated in the product risk management file as being linked to hazard with description fire, flame, smoke.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no further indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.The device mentioned in this complaint has exceeded its useful life per the applicable ifu.

• 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: 20925088
• Report Number: 2518422-2024-105504
• Device Sequence Number: 5107752
• Product Code: CAW
• UDI-Device Identifier: 00606959014954
• UDI-Public: (01)00606959014954
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: Not provided; 04/23/2026
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/02/2025; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2017
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White