EverFlo EVERFLO 120V w/O2 Percent Indicator, UltraFill, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959032675), received between Nov 17, 2016 and Feb 14, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2018Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT LIT A CIGARETTE WHILE USING AN EVERFLO OXYGEN CONCENTRATOR. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH FACIAL BURNS AND SMOKE INHALATION. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. 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: Burn(s); Burn, Thermal; Respiratory Distress

  MAUDE report 7270678 ↗
• MalfunctionJun 21, 2017Fire; Fire

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR CAUGHT ON FIRE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE HAD EVIDENCE OF THERMAL DAMAGE TO THE OUTLET PORT. THE THERMAL DAMAGE WAS CAUSED BY AN EXTERNAL SOURCE. THE DEVICE WAS TESTED AND WAS FOUND TO OPERATE AND ALARM TO DESIGN SPECIFICATIONS. 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: No Consequences Or Impact To Patient

  MAUDE report 6657410 ↗
• MalfunctionNov 17, 2016Device Operational Issue; Device Operational Issue; Device Contamination with Chemical or Other Material

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR EMITTED A WHITE POWDER. THE PATIENT BECAME SHORT OF BREATH AND WAS HOSPITALIZED FOR ONE DAY AND WAS RELEASED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Dyspnea; Increased Respiratory Rate

  MAUDE report 6109167 ↗