EverFlo EVERFLO QUIET, NON-O2 Percent Indicator, 120V, US, CARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959032637), received between Jul 13, 2022 and Mar 6, 2026 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 6, 2026Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Insufficient Information

  MAUDE report 24527919 ↗
• MalfunctionJul 13, 2022Thermal Decomposition of Device; Contamination; Thermal Decomposition of Device; Contamination

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR CAUGHT ON FIRE AND BURNT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURER VISUALLY INSPECTED THE DEVICE EXTERNALLY AND FOUND THE PATIENT TUBING TO HAVE IGNITED AND CAUSED COSMETIC DAMAGE TO THE DEVICE. THE DEVICE HAD EVIDENCE OF SEVERAL AREAS OF THERMAL DAMAGE THAT IS CONSISTENT WITH AN EXTERNAL SOURCE. AN INTERNAL INSPECTION OF THE DEVICE WAS COMPLETED BY THE MANUFACTURER. THE DEVICE HAS EVIDENCE OF CONTAMINATION OF DUST AND DIRT AND ODOR OF TAR AND NICOTINE. THERE WAS NO REPORT OF THERMAL DAMAGE INTERNALLY TO THE DEVICE. THE DEVICE COULD NOT BE TESTED TO DUE TO THE DAMAGE TO THE DEVICE. 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." THE MANUFACTURER CONCLUDES THE THERMAL DAMAGE WAS CAUSED BY AN EXTERNAL SOURCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004775 ↗