EverFlo EverFlo, w/Oxygen Percent Indicator, 230V, UltraFill, AURecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00606959020436), received between May 30, 2018 and Jul 21, 2025 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS CONTACTED ABOUT A DECEASED PATIENT. LAW ENFORCEMENT INFORMED THEM THAT THE DEVICE IS INVOLVED IN A HOMICIDE INVESTIGATION. THE DEVICE IS NOW IN LAW ENFORCEMENT CUSTODY. CURRENTLY, THERE IS NO EVIDENCE SUGGESTING THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE MANUFACTURER'S INVESTIGATION IS STILL IN PROGRESS, AND A FOLLOW-UP REPORT WILL BE PROVIDED ONCE IT IS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 22562018 ↗
• MalfunctionMar 29, 2022Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR HAD THERMAL DAMAGE TO THE POWER CORD. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943723 ↗
• MalfunctionMar 8, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR HAD THERMAL DAMAGE TO THE POWER CORD. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690964 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WAS SMOKING A CIGARETTE WHILE USING AN EVERFLO OXYGEN CONCENTRATOR. THE PATIENT WAS HOSPITALIZED WITH BURNS TO HER NOSE AND THROAT. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Burn(s)

  MAUDE report 11921438 ↗
• InjuryMay 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WAS SMOKING A CIGARETTE WHILE USING AN EVERFLO OXYGEN CONCENTRATOR. THE PATIENT RECEIVED BURNS AND WAS TAKEN TO THE HOSPITAL AND RELEASED ON THE SAME DAY. THE DEVICE IS NOT RETURNING TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION THAT OCCURRED. THE DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER CONFIRMED THE FIRE ORIGINATED AT THE END OF THE NASAL CANNULA. THE DEVICE HAS EVIDENCE OF THERMAL DAMAGE TO THE ENCLOSURE AND TO THE POWER CORD. THE DME HAS SCRAPPED THE DEVICE. THE DME RETURNED TO THE PATIENT'S HOME TO COLLECT THE DAMAGED EQUIPMENT AND FOUND THE PATIENT SMOKING A CIGARETTE. PRODUCT LABELING STATES, "OXYGEN VIGOROUSLY ACCELERATES COMBUSTION AND SHOULD BE KEPT AWAY FROM HEAT OR OPEN FLAME. NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE. DO NOT SMOKE, ALLOW OTHERS TO SMOKE OR HAVE OPEN FLAMES NEAR THE CONCENTRATOR WHEN IT IS IN USE."

  Patient problems: Burn(s)

  MAUDE report 7553355 ↗