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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959032606), received between Jan 28, 2021 and Jan 28, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2021Use 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 INFORMATION ALLEGING A PATIENT RECEIVED BURNS TO THEIR AIRWAYS WHILE USING AN EVERFLO OXYGEN CONCENTRATOR. THE DEVICE IS NOT BEING RETURNED TO THE MANUFACTURER'S SERVICE CENTER. THE DEVICE IS CURRENTLY STILL BEING USED BY THE PATIENT. PHOTOGRAPHS PROVIDED BY THE DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER WAS REVIEWED BY THE MANUFACTURER. IT APPEARS THE BURNS WERE FROM AN EXTERNAL SOURCE NEAR THE NASAL CANNULA. THE DEVICE HAS NO EVIDENCE OF THERMAL DAMAGE TO THE ENCLOSURE OF THE DEVICE. 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." THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF THERMAL DAMAGE TO THE DEVICE AND THAT THE BURNS SUFFERED BY THE PATIENT WAS FROM AN EXTERNAL SOURCE.

  Patient problems: Burn(s)

  MAUDE report 11245179 ↗