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

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00606959001077), received between Mar 15, 2017 and Dec 12, 2025 — classified as 4 deaths, 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING FROM THE PATIENT'S SON AND CAREGIVER THAT DUE TO A MALFUNCTION (UNSPECIFIED MALFUNCTION ALLEGEDLY DUE TO POOR/LACK OF MAINTENANCE FROM THE MEDICAL EQUIPMENT PROVIDER) OF THE DEVICE (EVERFLO OXYGEN CONCENTRATOR), THE PATIENT EXPERIENCED AN ADVERSE EVENT PROMPTING EMERGENCY MEDICAL SERVICES (EMS) TO BE CONTACTED. NO DEVICE EVALUATION WILL BE POSSIBLE BECAUSE IT WAS REPORTED TO THE MANUFACTURER THAT THE DEVICE HAS BEEN DESTROYED BY A FAMILY MEMBER. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795053 ↗
• InjuryDec 12, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE MANUFACTURER RECEIVED INFORMATION FROM THE PATIENT'S SON AND CAREGIVER ALLEGING THAT DUE TO A MALFUNCTION (UNSPECIFIED MALFUNCTION ALLEGEDLY DUE TO POOR/LACK OF MAINTENANCE FROM THE MEDICAL EQUIPMENT PROVIDER) OF THE DEVICE (EVERFLO OXYGEN CONCENTRATOR), THE PATIENT EXPERIENCED AN ADVERSE EVENT PROMPTING EMERGENCY MEDICAL SERVICES (EMS) TO BE CONTACTED. NO DEVICE EVALUATION WILL BE POSSIBLE BECAUSE IT WAS REPORTED TO THE MANUFACTURER THAT THE DEVICE HAS BEEN DESTROYED BY A FAMILY MEMBER. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794919 ↗
• InjuryDec 12, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING FROM THE PATIENT'S SON AND CAREGIVER THAT DUE TO A MALFUNCTION (UNSPECIFIED MALFUNCTION ALLEGEDLY DUE TO POOR/LACK OF MAINTENANCE FROM THE MEDICAL EQUIPMENT PROVIDER) OF THE DEVICE (EVERFLO OXYGEN CONCENTRATOR), THE PATIENT EXPERIENCED AN ADVERSE EVENT PROMPTING EMERGENCY MEDICAL SERVICES (EMS) TO BE CONTACTED. NO DEVICE EVALUATION WILL BE POSSIBLE BECAUSE IT WAS REPORTED TO THE MANUFACTURER THAT THE DEVICE HAS BEEN DESTROYED BY A FAMILY MEMBER. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794643 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM THE REPORTER (PATIENT'S SON AND CAREGIVER) ALLEGING THAT DUE TO A MALFUNCTION (UNSPECIFIED) OF THE DEVICE (EVERFLO OXYGEN CONCENTRATOR), THE PATIENT EXPERIENCED AN ADVERSE EVENT PROMPTING EMERGENCY MEDICAL SERVICES (EMS) TO BE CONTACTED. THE REPORTER (PATIENT'S SON) CONTACTED EMS AT 0605 LOCAL TIME ON THE DATE OF EVENT DUE TO THE PATIENT'S INCREASING SHORTNESS OF BREATH. THE REPORTER HAS ALLEGED THAT THE ADVERSE EVENT WAS DUE TO AN UNSPECIFIED DEVICE MALFUNCTION. EMS WAS REPORTED TO HAVE ARRIVED AT THE PATIENT'S LOCATION (HOME) AT 0620 LOCAL TIME. PATIENT EVALUATION WAS CONDUCTED ON ARRIVAL WITH VITALS REPORTED AS: SPO2 48% WITH THE PATIENT BREATHING ROOM AIR (DEVICE NOT CONNECTED TO PATIENT), RESPIRATORY RATE 36, HEART RATE 105, BLOOD PRESSURE 127/70. PATIENT ASSESSMENT FOUND THE PATIENT IN SEVERE RESPIRATORY DISTRESS, TACHYPNEIC, HYPOXIC, AND TACHYCARDIC. IT WAS UNCLEAR WHY THE PATIENT WAS NOT USING THE DEVICE IN QUESTION AT THE TIME OF ASSESSMENT, NOR WAS IT CLEAR IF THE PATIENT INCREASED SHORTNESS OF BREATH OCCURRED WHILE USING THE DEVICE. THE PATIENT WASN'T ABLE TO PROVIDE FURTHER ELABORATION. GLASGOW COMA SCALE WAS CONDUCTED WITH REP

  Patient problems: Adult Respiratory Distress Syndrome; Chronic Obstructive Pulmonary Disease (COPD); Dyspnea

  MAUDE report 23774873 ↗
• DeathNov 19, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION THROUGH A GOOD FAITH EFFORT ATTEMPT ON (B)(6) 2025, THAT AN EVENT OCCURRED IN AUSTRALIA. THIS INFORMATION WAS DISCOVERED WHEN REQUESTING DEVICE INFORMATION. IT WAS DURING THIS GOOD FAITH EFFORT ATTEMPT THE MANUFACTURER WAS MADE AWARE THAT THE INCIDENT HAD OCCURRED IN AUSTRALIA ON A EVERFLO DEVICE. SINCE IT IS UNCLEAR WHICH DEVICE THE ALLEGATION OF HARM IS AGAINST, THIS REPORT IS BEING SENT TO CAPTURE THE REPLACEMENT DEVICE SN (B)(6) MATERIAL NUMBER (1020010) EVERFLO INTL OPI 230V AUSTRALIA, (B)(4). THE (ORIGINAL DEVICE) SN (NOT CONFIRMED) (EVERFLO INTL OPI 230V AUSTRALIA) WILL HAVE ALL REPORTING DONE UNDER (B)(4). THIS ALLEGATION IS THAT A PATIENT'S USING A REPLACEMENT EVERFLO DEVICE EXPERIENCED A CHEST INFECTION, WHICH IN TURN RESULTED IN DEATH. THE PATIENT'S SON STATES THE DEVICE WAS A REPLACEMENT DUE TO THE PATIENT'S ORIGINAL DEVICE "APPEARED TO DELIVER INSUFFICIENT OXYGEN WHILE FAILING TO TRIGGER ANY ALARMS OR WARNINGS" DURING WHICH IN TIME THE PATIENT'S SATURATION CONSISTENTLY AVERAGED AROUND 87% AND HE EXPERIENCED A MARKED DECLINE IN COGNITIVE AND PHYSICAL HEALTH WHICH CONTINUED FOR SEVERAL MONTHS BEFORE THE DEVICE WAS REPLACED

  Patient problems: Unspecified Infection

  MAUDE report 23600549 ↗
• DeathNov 10, 2025Insufficient Flow or Under Infusion; Adverse Event Without Identified Device or Use Problem; Insufficient Flow or Under Infusion; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE PATIENT'S EVERFLO DEVICE "APPEARED TO DELIVER INSUFFICIENT OXYGEN WHILE FAILING TO TRIGGER ANY ALARMS OR WARNINGS" DURING WHICH TIME THE PATIENT'S OXYGEN SATURATION CONSISTENTLY AVERAGED AROUND 87% AND HE EXPERIENCED A MARKED DECLINE IN COGNITIVE AND PHYSICAL HEALTH WHICH CONTINUED FOR SEVERAL MONTHS BEFORE THE DEVICE WAS REPLACED, AT WHICH POINT HIS OXYGEN SATURATIONS RETURNED TO "NORMAL LEVELS". THE REPORTER STATED THAT GIVEN THESE OBSERVATIONS, THEY ARE "DEEPLY CONCERNED THAT THE CONCENTRATOR MAY HAVE BEEN OPERATING BELOW ITS INTENDED OXYGEN CONCENTRATION OUTPUT WITHOUT ANY INDICATION OF MALFUNCTION." THE REPORTER STATED THAT THEY HAVE RECORDS OF OXYGEN SATURATION READINGS, HOSPITAL AND AMBULANCE REPORTS, AND OTHER DOCUMENTATION THAT CLEARLY SHOW THE PROGRESSIVE IMPACT THIS FAULT HAD ON THEIR FATHER¿S HEALTH. THE REPORTER STATED THAT THEIR LATE FATHER WAS ON THE DEVICE FOR COPD ¿ EMPHYSEMA. THE REPORTER STATED THAT THE OXYGEN CONCENTRATOR IS NO LONGER AVAILABLE FOR RETURN BECAUSE IT WAS DESTROYED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Insufficient Information

  MAUDE report 23514271 ↗
• MalfunctionOct 27, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF EVERFLO DEVICE STATING UNIT SPARKED AND DAMAGED THE WALL SOCKET. IT DID NOT TRIP THE MAIN POWER BOX. UPON INSPECTION IN THE WORKSHOP, ONE AC POWER HAS SIGNS OF BURNING AND CORROSION WITH MELTING VISIBLE ON THE SURROUNDING PLASTIC. THE TECH ARRIVED ONSITE AND REPORTED THAT IS MELTED THE PLUG HEAD AND DAMAGED THE WALL SOCKET. THEY ARE CONCERNED AS IT DIDN'T TRIP THE MAIN POWERBOX, FOR WHICH COULD BE A HOUSE ISSUE. UNIT HAS BEEN REPLACED. 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. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399259 ↗
• MalfunctionApr 15, 2024Sparking; Sparking

  THE MANUFACTURER BECAME AWARE OF REPORTED SPARKING COMING FROM OUT OF THE BACK OF A POWER CORD FOR AN EVERFLO OPI CONCENTRATOR. THE COATING HAS MELTED ON THE BACK OF THE POWER PLUG BEFORE THE UNIT. THERE WAS NO PATIENT HARM OR INJURY REPORTED. NO MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED TO THE DISTRIBUTOR WHERE THE INSULATOR OF THE POWER CORD WAS FOUND TO BE PEELED OFF AND HAD AN EXPOSED CONDUCTOR WIRE. SPARKS WERE UNABLE TO BE REPLICATED AS REPAIR OF THE DEVICE WAS CONDUCTED FIRST BEFORE PLUGGING THE UNIT INTO AC POWER FOR SAFETY REASONS. THE CORRECTIVE ACTIONS TAKEN WERE TO REPLACE THE POWER CORD, COMPRESSOR, THE SIEVE CANNISTER AND CHANGE THE INTERNAL FILTER BEFORE TURNING ON THE DEVICE UPON RECEIPT. THE CONCENTRATOR WAS TESTED AND CONFIRMED TO BE WORKING CORRECTLY. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111165 ↗
• DeathMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT A USER OF AN EVERFLO INTL. OPI CONCENTRATOR LOST POWER DUE TO LOCAL POWER BLACKOUT OUTAGE. THE USER WAS FOUND ON THE FLOOR NEXT TO HER BEDSIDE TABLES DECEASED. THE SON STATED THAT HE THOUGHT HIS MUM WAS TRYING TO GET THE OXYGEN BOTTLES AND FELL. THE USER WAS REGISTERED AS A LIFE-SUPPORT PATIENT WITH THE ELECTRIC COMPANY, WHICH DURING SCHEDULED MAINTENANCE OUTAGES FAMILY MEMBERS ARE NOTIFIED BUT NOT IN THE CASE DURING AN UNPLANNED BLACKOUT. ALLEGATION AS DESCRIBED IN THE NEWSPAPER ARTICLE WAS NOT DUE TO DEVICE MALFUNCTION HOWEVER THE CONCERN THAT THE POWER OUTAGE SHUT OFF THE CONCENTRATOR AND THEREFORE OXYGEN SUPPLY TO THE PATIENT CEASED. THE USER NEEDED THE OXYGEN FOR HER EMPHYSEMA. THE FAMILY HAS NOT RETURNED CALLS REQUESTING THE DEVICE BE RETURNED. NO PRODUCT RETURNING. IF FURTHER INFORMATION BECOMES AVAILABLE REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Myocardial Infarction

  MAUDE report 17000133 ↗
• InjuryOct 28, 2020Use of Device Problem; Use of Device Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR WAS BEING USED NEAR A CANDLE AND CAUGHT FIRE. THE PATIENT SUFFERED BURNS AND WAS HOSPITALIZED. THERE WAS NO REPORT OF DEVICE MALFUNCTION THAT CAUSED THE EVENT. 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 10749942 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT LIT A CIGARETTE WHILE USING THE EVERFLO OXYGEN CONCENTRATOR. THE PATIENT RECEIVED BURNS AND WAS HOSPITALIZED. THE INVESTIGATION IS STILL ONGOING FOR THIS ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Burn(s)

  MAUDE report 7458262 ↗
• DeathMar 15, 2017Adverse 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 NASAL CANNULA IGNITED AND THE PATIENT REPORTEDLY EXPIRED FROM HIS INJURIES. THE DEVICE WAS RETURNED TO THE REPORTING FACILITY FOR EVALUATION ON 10/15/2016. THE DEVICE WAS EVALUATED AND WAS FOUND TO OPERATE PROPERLY. THERE WAS NO EVIDENCE OF THERMAL DAMAGE OBSERVED. THE DEVICE WAS RETURNED TO THE RENTAL STOCK. THE DEVICE IS CURRENTLY IN PATIENT USE. 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: Death

  MAUDE report 6407128 ↗