EVOLUTION OM-904JRecalls & reported problems
Inovo, Inc. · EVOLUTION ELECTRONIC OXYGEN CONSERVER · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814470020198), received between May 31, 2017 and May 31, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “No Flow” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- No Flow1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 31, 2017No Flow; No Flow
IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING OXYGEN WHILE IN THE CONSERVE MODE AND THE DEVICE IS DISPLAYING A CONSTANT BLINKING LIGHT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR AN UNKNOWN REASON. THE STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME. MULTIPLE ATTEMPTS TO GATHER ADDITONAL INFORMATION WERE UNSUCESSFUL.
Patient problems: No Code Available
MAUDE report 6603059 ↗
Other Conserver, Oxygen devices
- AirLife™ SFT2601Vyaire Medical, Inc. · Conserver, oxygen4 reports
- AirLife™ FM2699Vyaire Medical, Inc. · Conserver, oxygen2 reports
- Evolution™ OM-900Inovo, Inc. · Conserver, Oxygen2 reports
- Drive OM-900AInovo, Inc. · Conserver, Oxygen2 reports
- ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR IN6505-L-BLUEInovo, Inc. · Conserver, Oxygen2 reports
- EVOLUTION OM-900AInovo, Inc. · Conserver, Oxygen1 report
- Drive P-224Drive Devilbiss Healthcare · Conserver, oxygen1 report
- AirLife™ SFT2699Vyaire Medical, Inc. · Conserver, oxygen1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.