EverFlo EVERFLO w/Oxygen Percentage Indicator, 230V, ZARecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00606959032583), received between Sep 19, 2018 and May 22, 2025 — classified as 1 death, 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (5 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• DeathMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT PATIENT HAS PASSED AWAY. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069584 ↗
• MalfunctionJul 18, 2024Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem; Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF EVERFLO INTL OPI THAT THE PATIENT ALLEGES THAT THE DEVICE HAS DAMAGED POWER CORD. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THEY FOUND OUT THAT THE COMPLAINT WAS CONFIRMED. REPLACED POWER CORD, INTEGRATED SIEVE CANISTER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19776873 ↗
• MalfunctionJul 12, 2024Fire; Fire

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO AN EVERFLO DEVICE. THE USER ALLEGES POWER CORD BURN, DEFECTIVE POWER CORD & INLET FILTER. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE HAS NOT YET 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730424 ↗
• MalfunctionApr 8, 2024Crack; Crack

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN EVERFLO DEVICE WITH AN ALLEGATION OF THE POWER CORD BEING DAMAGED. THE COMPLAINT WAS EVALUATED BY A FASC. THE COMPLAINT WAS CONFIRMED, AND THE DAMAGED POWER CORD WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068738 ↗
• MalfunctionJan 24, 2024Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF EVERFLO INTL OPI THAT THE PATIENT ALLEGES THAT THE DEVICE IS DEFECTIVE. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THEY FOUND OUT THAT THE COMPLAINT WAS CONFIRMED, THE POWER CODE IS DEFECTIVE, THE LED NOT WORKING AND LOW 02, NOISE, FUSE, MANIFOLD, TUBING KIT, SIEVE KIT, AND INLET FILTER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570614 ↗
• MalfunctionJan 17, 2024Fracture; Fracture

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN EVERFLO OXYGEN CONCENTRATOR. THE COMPLAINT REFERENCES THE POWER CORD BEING DAMAGED. THERE IS NO ALLEGATION OF PATIENT HARM OR SERIOUS INJURY. NO CLINICAL OR MEDICAL INFORMATION WAS PROVIDED. THE DEVICE WAS INSPECTED AND EVALUATED, AND THE POWER CORD WAS REPLACED BY A THIRD-PARTY SERVICE CENTER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531339 ↗
• MalfunctionJan 17, 2024Break; Break

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN EVERFLO OXYGEN CONCENTRATOR. THE COMPLAINT REFERENCES A RED ALARM, DEFECTIVE PCA, AND A POWER CORD. THERE IS NO ALLEGATION OF PATIENT HARM OR SERIOUS INJURY. NO CLINICAL OR MEDICAL INFORMATION WAS PROVIDED. THE DEVICE WAS INSPECTED AND EVALUATED, AND THE POWER CORD AND MAIN PCA WERE REPLACED BY A THIRD-PARTY SERVICE CENTER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18529433 ↗
• MalfunctionMar 15, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THERMAL DAMAGE TO THE CAPACITOR OF AN EVERFLO OXYGEN CONCENTRATOR. 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 16543358 ↗
• MalfunctionJun 29, 2022Thermal Decomposition of Device; Electrical /Electronic Property Problem; Thermal Decomposition of Device; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD PARTY SERVICE CENTER ALLEGING AN EVERFLO OXYGEN CONCENTRATOR HAD THERMAL DAMAGE TO THE POWER CORD. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, THE DEVICE HAD EVIDENCE OF THE POWER CORD BEING BURNED. THERE WAS NO REPORT OF EXPOSED WIRES. THE POWER CORD WAS REPLACED TO ADDRESS THE ISSUE. PRODUCT LABELING STATES",DO NOT USE THE OXYGEN CONCENTRATOR IF EITHER THE PLUG OR POWER CORD IS DAMAGED. DO NOT USE EXTENSION CORDS OR ELECTRICAL ADAPTERS. " SEVERAL ATTEMPTS HAVE BEEN MADE TO HAVE THE PART RETURNED BUT HAVE BEEN NOT SUCCESSFUL. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854278 ↗
• InjuryApr 7, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR'S FLOW METER FLUCTUATES. THE PATIENT'S CO2 LEVEL INCREASED AND THE PATIENT WAS HOSPITALIZED. THE DEVICE WAS EVALUATED AT A THIRD PARTY SERVICE CENTER. THE THIRD PARTY SERVICE CENTER FOUND NO ISSUES WITH THE DEVICE.

  Patient problems: Hypoventilation

  MAUDE report 14047225 ↗
• MalfunctionJan 17, 2019Thermal Decomposition of Device; Thermal Decomposition of Device

  AN EVERFLO OXYGEN CONCENTRATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, THERMAL DAMAGE TO THE POWER CORD WAS OBSERVED. THE DEVICE'S POWER CORD WAS REPLACED TO ADDRESS THE ISSUE. PRODUCT LABELING STATES,"DO NOT USE THE OXYGEN CONCENTRATOR IF EITHER THE PLUG OR POWER CORD IS DAMAGED. DO NOT USE EXTENSION CORDS OR ELECTRICAL ADAPTERS. KEEP THE DEVICE AT LEAST 15 TO 30 CM AWAY FROM WALLS, FURNITURE, AND ESPECIALLY CURTAINS THAT COULD IMPEDE ADEQUATE AIRFLOW TO THE DEVICE. DO NOT PLACE THE CONCENTRATOR IN A SMALL CLOSED SPACE (SUCH AS A CLOSET)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257841 ↗
• MalfunctionNov 14, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD PARTY SERVICE CENTER ALLEGING AN EVERFLO OXYGEN CONCENTRATOR HAD THERMAL DAMAGE TO THE POWER CORD. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE, THERMAL DAMAGE TO THE POWER CORD WAS OBSERVED. THE POWER CORD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8069178 ↗
• MalfunctionSep 19, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  AN EVERFLO OXYGEN CONCENTRATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, THERMAL DAMAGE TO THE POWER CORD WAS OBSERVED. THE POWER CORD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889649 ↗