Skip to content

EVOLUTION OM-900ARecalls & reported problems

Inovo, Inc. · Evolution Electronic Oxygen Conserver · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814470020150), received between May 31, 2017 and May 31, 2017 — classified as 1 malfunction.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A HOME OXYGEN SUPPLIER (CUSTOMER) IN (B)(6) REPORTED THAT THEY RECEIVED A REPORT FROM A HOME OXYGEN USER (PATIENT), WHICH INVOLVED THE EVOLUTION TM OXYGEN CONSERVING DEVICE (OCD). ACCORDING TO THE HOME OXYGEN SUPPLIER'S REPORT, THE PATIENT WAS CHANGING THE OCD FROM AN EMPTY CYLINDER TO A FULL CYLINDER WHEN THE EVENT OCCURRED. "THE OCD WAS CONNECTED, AND AFTER TURNING ON THE CYLINDER VALVE THERE WAS AN EXPLOSION WITH THE CUSTOMER SEEING SPARKS." THERE WERE NO INJURIES OR DAMAGE RELATED TO THIS EVENT. WHILE THE TERM "EXPLOSION" WAS USED IN THE CUSTOMER REPORT, THIS WAS IN REFERENCE TO THE LOUD NOISE CAUSED BY THE SOUND OF HIGH PRESSURE GAS ESCAPING FROM THE LEAK. THERE IS NO EVIDENCE OF AN ACTUAL EXPLOSION. A FUNCTIONALITY TEST OF THE OCD WAS PERFORMED BY THE CUSTOMER AND IT WAS DETERMINED THAT THE DEVICE WAS OPERATING AS INTENDED. AS PART OF THE HOME OXYGEN SUPPLIER'S REPORT AND INTERNAL INVESTIGATION, THEY RETRIEVED THE OCD AND CYLINDER INVOLVED IN THE EVENT FOR EVALUATION, AND OBSERVED THE FOLLOWING: DARK RESIDUE WHICH MAY INDICATE BURN MARKS ON THE CONSERVER OXYGEN INLET BUT NO VISIBLE DAMAGE TO THE DEVICE, THE SEAL WASHER IS CORRECT FOR THE DEVICE AND IS INTACT, WITH WHAT APPEAR

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6603223 ↗

Other Conserver, Oxygen devices

All Conserver, Oxygen devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.