EverFlo EVERFLO QUIET w/O2 Percent Indicator, 120V, UltraFill, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959032682), received between Dec 27, 2017 and Mar 8, 2024 — classified as 3 deaths.

The most frequently reported specific device problem is “Fire” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathMar 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION REGARDING AN EVERFLO DEVICE. THE FAMILY OF THE PATIENT REPORTED A RED LIGHT CAME ON THE DEVICE THE NIGHT BEFORE, AND WHEN THEY CHECKED THE NEXT MORNING, THE PATIENT HAD EXPIRED. NO MEDICAL INTERVENTION WAS REPORTED. NO PATIENT INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865288 ↗
• DeathFeb 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT BECAME DISCONNECTED FROM THE EVERFLO OXYGEN CONCENTRATOR AND EXPIRED. THE DEVICE IS NOT RETURNING TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. IT WAS REPORTED TO THE MANUFACTURER THAT THE DEVICE OPERATED PROPERLY AT THE DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER WHEN TESTED. PRODUCT LABELING STATES, "THE DEVICE IS NOT INTENDED TO BE LIFE SUPPORTING OR LIFE SUSTAINING."

  Patient problems: Death

  MAUDE report 7303972 ↗
• DeathDec 27, 2017Fire; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR WAS INVOLVED IN A HOUSE FIRE. THE PATIENT WAS IN HOSPICE CARE AT THE TIME OF THE EVENT. THE REPORTING FACILITY CONFIRMED THE PATIENT EXPIRED PRIOR TO THE FIRE. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Death

  MAUDE report 7148642 ↗