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EverFlo EVERFLO w/Oxygen Percentage Indicator, 120V, L.ARecalls & reported problems

Respironics, Inc. · EverFlo with OPI, 120V, L.A. · Class 2

All models of EverFlo (20)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959032514), received between Dec 15, 2017 and Sep 29, 2021 — classified as 1 death, 1 malfunction.

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

Device problems

  • Device Operates Differently Than Expected1
  • Device Operational Issue1
  • Fire1

Patient problems

  • Death1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 29, 2021Fire; Fire

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR CAUGHT ON FIRE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12546540 ↗
  • DeathDec 15, 2017Device Operates Differently Than Expected; Device Operational Issue; Device Operational Issue

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR WAS NOT WORKING PROPERLY AND THE PATIENT EXPIRED. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Patient problems: Death

    MAUDE report 7121116 ↗

Other Generator, oxygen, portable devices

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Sources and updates

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