EverFlo EverFlo w/O2 Percentage Indicator, 230V, EURecalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00606959032552), received between Nov 16, 2016 and Sep 11, 2026 — classified as 5 deaths, 16 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (23 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 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Thermal Decomposition of Device

  The manufacturer received information alleging no flow and burning smell. The device settings during the event were reported to be unknown. There was no allegation of serious or permanent harm or injury. No medical intervention was specified by the patient. Preliminary findings found that the clogged sieve caused the compressor to become overloaded and overheat, resulting in a burning smell. During the evaluation, the debug technician also noticed that the manifold was melted. Based on these findings, the sieves need to be replaced. Additionally, the inside of the rear cabinet is damaged, the whisper cap is cracked, and the capacitor is electrically defective. The inlet filter was replaced as part of preventive maintenance. The device was returned unrepaired to the manufacturer's Product Investigation Lab (PIL) for further investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725444 ↗
• MalfunctionSep 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50657951 ↗
• MalfunctionAug 17, 2026Thermal Decomposition of Device

  The device was sent to a third-party service center for investigation. During the evaluation, the third-party service center noted a melted cable. The device will be forwarded to the manufacturer¿s Product Investigation Lab (PIL) for additional testing and investigation. A follow up report will be sent once the investigation is concluded.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268677 ↗
• MalfunctionAug 13, 2026Thermal Decomposition of Device

  The device was sent to a third-party service center for investigation. During the evaluation, the third-party service center found that the unit had a burned capacitor and that the PCA and fuse were also burned. Due to the alleged malfunction, the device will be forwarded to the manufacturer¿s Product Investigation Lab (PIL) for additional testing and investigation. A final report will be sent once the investigation is concluded.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50242684 ↗
• MalfunctionAug 13, 2026Thermal Decomposition of Device

  The device was sent to a third-party service center for investigation. During evaluation, the third-party service center found a burnt PCA. Due to the alleged malfunction, the device will be forwarded to the manufacturer¿s Product Investigation Lab (PIL) for additional testing and investigation. A final report will be sent once the investigation is concluded.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50242680 ↗
• MalfunctionAug 6, 2026Thermal Decomposition of Device

  This notification was opened for review for information received that the EVERFLO INTL OPI 230V device stating a confirmed complaint due to found device has "thermal damage - power cord burnt" and leak zeolite. The device is pending return and evaluation. If any additional information is received, a follow up report will be filed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160429 ↗
• MalfunctionAug 6, 2026Thermal Decomposition of Device

  A device was returned to a third-party service center in reference to an allegation the device would not start.During the evaluation of the device, the third-party service center visually inspected the device and found evidence showing the devices PCA was burned. The device has not been evaluated by the manufacturer¿s Product Investigation Lab (PIL) for additional testing and investigation at this time. 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 50160063 ↗
• MalfunctionJul 16, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25846980 ↗
• MalfunctionJul 14, 2026Break; Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25818041 ↗
• MalfunctionJul 10, 2026Smoking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25779891 ↗
• MalfunctionJun 25, 2026Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE DEVICE EMITTED SMOKE FROM THE FILTER CABINET DURING USE. ADDITIONALLY, THE POWER PLUG WAS PARTIALLY MELTED. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25628287 ↗
• MalfunctionJun 25, 2026Thermal Decomposition of Device; Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION THAT AFTER SIX HOURS OF OPERATION, THE "VENTILATION TUBE" OF AN EVERFLO DEVICE CAUGHT FIRE DUE TO A SMALL EXPLOSION. WHILE TRYING TO PUT IT OUT, THE PATIENT REPORTED THAT THEY BURNED THEIR HAND, AND THE FRESHLY RENOVATED WOODEN FLOOR CAUGHT FIRE FROM THE MELTED BURNING TUBE, WHICH DAMAGED THE FLOOR AND AFFECTED THE FRESHLY PAINTED WALL. THE FIRE WAS EXTINGUISHED USING A BOTTLE OF STILL MINERAL WATER, NO FURTHER DAMAGE OCCURRED. NO MEDICAL INTERVENTION/TREATMENT OR FURTHER CLINICAL DETAILS WERE REPORTED. IT WAS REPORTED THAT THE DATE OF INCIDENT WAS (B)(6) 2026. THE DEVICE SETTINGS DURING THE EVENT WERE REPORTED TO BE UNKNOWN. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE CLINICAL ASSESSMENT STATES THAT, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE REPORTED EVENT OF UNSPECIFIED BURN TO THE HAND IS ASSESSED AS A NON-SERIOUS INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION REQUIRED OR RECEIVED TO PRECLUDE A LIFE-THREATENING INJURY OR PERMANENT IMPAIRMENT. THEREFORE, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.' THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25626952 ↗
• MalfunctionJun 8, 2026Smoking

  THE MANUFACTURER RECEIVED INFORMATION REGARDING AN EVERFLO DEVICE FOLLOWING AN ALLEGATION OF BURNING SMELL AND SMOKE. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE DID NOT ALARM, WOULD NOT POWER ON, AND DID NOT DISPLAY HOURS. NO VISIBLE BURN MARKS WERE FOUND ON THE CABLE, PLUG, OR THE DEVICE ITSELF. A TECHNICAL EVALUATION PERFORMED BY THE REPAIR SHOP DETERMINED THAT THE MAIN BOARD WAS FAULTY. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY, AND THE PATIENT DID NOT REPORT RECEIVING ANY MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437667 ↗
• MalfunctionMay 22, 2026Fire

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO AN EVERFLO DEVICE INDICATING THAT THE DEVICE CAUSED FIRE IN THE PATIENT'S HOME. THE REPORTED EVENT INCLUDES NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260680 ↗
• MalfunctionApr 17, 2026Overheating of Device

  AN EVERFLO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH ALLEGATION OF RAR BURNT. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, THE SERVICE CENTER OBSERVED AND CONFIRMED THE ALLEGATION. ADDITIONALLY, DEVICE WAS SENT TO PIL FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916575 ↗
• MalfunctionApr 1, 2026Temperature Problem

  A EVERFLO INTL DEVICE WAS RETURNED TO A SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, THE DEVICE COMPRESSOR WAS BURN. THERE WAS NO EVIDENCE OF FOAM PARTICLES OR DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757766 ↗
• MalfunctionMar 30, 2026Smoking

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED AN EVERFLO CONCENTRATOR EMITTING SMOKE AND SUBSEQUENTLY STOPPED FUNCTIONING. HOWEVER, DURING THE TECHNICAL INSPECTION AT THE REPAIR SHOP, THE EQUIPMENT REACHED NINETY PERCENT OXYGEN CONCENTRATION AT FIVE LPM, AND NO ACTIVE ALARMS OR MALFUNCTIONS WERE DETECTED. THE NURSE MAINTAINED THAT THERE HAD BEEN A BURNING SMELL AT THE TIME OF THE EVENT. THE DEVICE WAS INSPECTED AND FOUND TO BE OPERATING CORRECTLY, WITH NO ANOMALIES DETECTED OR ISSUES REQUIRING CORRECTION BEYOND USER INSTRUCTION. DESPITE THIS, THE DEVICE AND ALL CONSUMABLES WERE REPLACED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730637 ↗
• MalfunctionMar 26, 2026Fire; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A FIRE INVOLVING THE OXYGEN EXTENSION TUBE CONNECTED TO THE CONCENTRATOR. THE OUTLET NOZZLE OF THE DEVICE AND APPROXIMATELY 1 METER OF THE EXTENSION TUBE WERE BURNED. THE PATIENT WAS NOT BURNED, BUT SPARKS REACHED HER CLOTHING DURING THE EVENT. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702526 ↗
• MalfunctionMar 25, 2026Thermal Decomposition of Device; Smoking

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE DEVICE BEGAN EMITTING BLACK SMOKE AND A STRONG BURNING SMELL FROM THE TRANSFORMER WHILE CONNECTED DIRECTLY TO A WALL OUTLET. THE PATIENT WAS IMMEDIATELY SWITCHED TO THE BACKUP OXYGEN CYLINDER. TECHNICAL ANALYSIS AT THE REPAIR SHOP CONFIRMED THE DEVICE IS IN CRITICAL CONDITION; SPECIFICALLY, THE POWER CABLE HAD MELTED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24692036 ↗
• MalfunctionMar 23, 2026Overheating of Device

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A EVERFLO DEVICE. THERE WAS AN ALLEGATION OF BROKEN CABLE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING EVALUATION, THE TECHNICIAN OBSERVED THAT THE POWER CORD WAS BURNT. UPON REVIEW OF THE EVENT, THE SERVICE CENTER HAS BEEN INSTRUCTED TO RETURN THE DEVICE TO THE MANUFACTURER PRODUCT INVESTIGATION LABORATORY (PIL) FOR FURTHER INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663417 ↗
• DeathFeb 26, 2026Fire; Improper or Incorrect Procedure or Method

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A EVERFLO DEVICE HAS PASSED AWAY. THE PATIENT'S GRANDSON REPORTS THE PATIENT WAS SMOKING A CIGARETTE WHILE USING THE OXYGEN. THE PATIENT WAS ALONE AT THE TIME OF THE ACCIDENT, AND A FIRE BROKE OUT THAT CAUSED SEVERE BURNS. THE PATIENT WAS FOUND BY THE CARER, WHO WAS ABLE TO PREVENT THE FIRE FROM SPREADING THROUGHOUT THE FLAT. THE PATIENT WAS THEN HOSPITALIZED FOR SEVERE BURNS AND THEN PASSED AWAY. WHEN THE EQUIPMENT WAS RECOVERED IT WAS FOUND THAT THE FIRE HAD BEEN BROUGHT UNDER CONTROL BEFORE REACHING BEFORE REACHING THE FIRE BREAK. THE CONCENTRATOR OF THE DEVICE WAS NOT AFFECTED. THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Burn(s)

  MAUDE report 24462273 ↗
• DeathFeb 3, 2026Use of Incorrect Control/Treatment Settings

  THIS NOTIFICATION WAS REVIEWED DUE TO A PATIENT PASSING AWAY ON (B)(6) 2025; HOWEVER, THE DEATH IS UNRELATED AS IT WAS REPORTED THE INJURY DID NOT RESULT IN PERMANENT IMPAIRMENT TO BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE. THE RESPIRATORY INSUFFICIENCY WAS TREATED VIA HOSPITALIZATION. THE DEVICE WAS BEING USED OFF LABEL AS THE PATIENT WAS PRESCRIBED 2L/MIN OF OXYGEN WHILE THE IN-HOME FLOWMETER WOULD ONLY DELIVER A MAXIMUM OF 1L/MIN. IF FURTHER INFORMATION BECOMES AVAILABLE, AN ADDITIONAL REPORT WILL BE FILED. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24249053 ↗
• MalfunctionFeb 2, 2026Excessive Heating

  THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND A BURNT POWER CORD. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS CONCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24230841 ↗
• MalfunctionJan 20, 2026Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO DEVICE HAD PURITY ISSUE. THERE WAS NO DEATH, SERIOUS HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE SERVICE TECHNICIAN FOUND THE SIEVES WERE CLOGGED, OUTLET COVER MISSING, CAPACITOR WAS DISCHARGED, COMPRESSOR ELECTRICALLY WAS DEFECTIVE, THE POWER CABLE BURNED, AND PCA WAS DAMAGED, IT DID NOT START UP. INLET FILTERS NEED TO BE REPLACED DUE TO PREVENTIVE MAINTENANCE. ALL PARTS NEED TO BE REPLACED. THE DEVICE WAS NOT REPAIRED BY THE THIRD-PARTY SERVICE CENTER AND WILL BE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LAB (PIL) FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119467 ↗
• MalfunctionJan 15, 2026Thermal Decomposition of Device; Overheating of Device; Unintended Electrical Shock

  THE MANUFACTURER RECEIVED INFORMATION REGARDING AN EVERFLO DEVICE FOLLOWING AN ALLEGATION OF ELECTRIC SHOCK AND BURNING. THE EQUIPMENT WAS BLACK FOR THE INCIDENT, AND THE PATIENT WAS IMMEDIATELY SWITCHED TO A BACKUP OXYGEN SOURCE. A FOLLOW-UP VISIT FOUND THE DEVICE WAS IN GOOD CONDITION WITH NO FRAYED OR STRIPPED WIRES AND IT WAS NOT PLUGGED IN FOR SAFETY REASONS. ADDITIONALLY, THE SERIAL NUMBER PROVIDED FOR THE EVERFLO OXYGEN CONCENTRATOR (B)(6) SN (B)(6) WAS NOT FOUND IN THE DATABASE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY AND THE PATIENT DID NOT REPORT RECEIVING ANY MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085669 ↗