Inogen One G3 Oxygen Concentrator 840 (REF IO-300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817131020032), received between Jul 10, 2021 and May 11, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K032818); they may or may not involve this specific model.

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

• MalfunctionMay 11, 2022No Flow; No Flow

  IT WAS REPORTED THE PATIENT EXPERIENCED NO OXYGEN OUTPUT FROM THE DEVICE. IN TURN, THE PATIENT SWITCHED UNITS AND LATER EXPERIENCED "SYSTEM HOT ERROR MESSAGE." AS A RESULT, THE PATIENT WAS TAKEN TO THE HOSPITAL AND ADMITTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 14355550 ↗
• MalfunctionJul 10, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A UNIT SHUT DOWN. IN TURN, THE PATIENT VISITED THE EMERGENCY ROOM.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12148159 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032818. One submission often covers many models, so check the product and lot details in each record.

• Z-1368-05 · Aug 1, 2005 · Terminated
  Portable Oxygen Generator