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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959032774), received between Dec 13, 2017 and Apr 2, 2021 — classified as 2 deaths, 2 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR MAY HAVE BEEN INVOLVED IN A HOUSE FIRE. THE PATIENT EXPIRED. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 11607148 ↗
• DeathOct 3, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPIRED WHILE USING AN EVERFLO OXYGEN CONCENTRATOR WITH A VENTILATOR. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Death

  MAUDE report 7929997 ↗
• InjuryJul 19, 2018No Audible Alarm; Failure to Deliver; No Audible Alarm; Failure to Deliver

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR HAD NO FLOW AND DID NOT ALARM. THE PATIENT WENT TO THE HOSPITAL FOR ONE NIGHT. THE DEVICE WAS EVALUATED BY A THIRD PARTY SERVICE CENTER. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. THE DEVICE WAS FOUND TO OPERATE AND ALARM TO SPECIFICATIONS. THE DEVICE WAS FOUND TO BE CONTAMINATED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7703750 ↗
• InjuryDec 13, 2017Device Operates Differently Than Expected; Device Operational Issue; Device Operational Issue

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR WAS NOT WORKING PROPERLY. THE PATIENT WAS HOSPITALIZED. 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 Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 7113489 ↗