Evolution™ OM-900Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814470020044), received between Aug 24, 2023 and Feb 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Temperature 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 21, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  INOVO PREVIOUSLY REPORTED AN INCIDENT INVOLVING AN OXYGEN CONSERVING DEVICE. THE PROVIDER REPORTED THAT THE END-USER STATED HE INSTALLED [ATTACHED] THE CONSERVER ONTO A CGA-870 OXYGEN CYLINDER. AFTER ATTACHING THE CONSERVING DEVICE, HE "OPENED THE CYLINDER WITH A PLASTIC WRENCH" AND THEN "HEARD A LEAK AND SAW A SPARK AND A FLAME," WHICH HE CLAIMED CAUSED A SMALL BURN ON HIS FINGER. HE IMMEDIATELY TURNED THE CYLINDER OFF TO STOP THE FLOW OF OXYGEN. THE END-USER DID NOT SEEK MEDICAL ATTENTION FOR THE ALLEGED INJURY. THE INFORMATION PRESENTED IS CONSISTENT WITH AN EVENT THAT MAY OCCUR WHEN A CONSERVING REGULATOR IS NOT PROPERLY ATTACHED TO THE CYLINDER, ALLOWING FOR A HIGH-PRESSURE LEAK. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE EXPERIENCED AN EXTERNAL IGNITION EVENT ORIGINATING AT THE CONNECTION OF THE SEAL WASHER WITH THE CGA VALVE. THE EVENT WAS LIKELY CAUSED BY AN UNAUTHORIZED SERVICING/TAMPERING WITH THE DEVICE AND INSTALLATION OF NON -MANUFACTURER APPROVED SEAL WASHER. THE MANUFACTURER INCORRECTLY REPORTED THIS REPORT ON FEI (B)(4).

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 18749618 ↗
• MalfunctionAug 24, 2023Temperature Problem; Temperature Problem

  INOVO WAS NOTIFIED BY A HOME OXYGEN PROVIDER OF AN INCIDENT INVOLVING AN OXYGEN CONSERVING DEVICE. THE PROVIDER REPORTED THAT THE END-USER STATED HE INSTALLED [ATTACHED] THE CONSERVER ONTO A CGA-870 OXYGEN CYLINDER. AFTER ATTACHING THE CONSERVING DEVICE, HE "OPENED THE CYLINDER WITH A PLASTIC WRENCH" AND THEN "HEARD A LEAK AND SAW A SPARK AND A FLAME," WHICH HE CLAIMED CAUSED A SMALL BURN ON HIS FINGER. HE IMMEDIATELY TURNED THE CYLINDER OFF TO STOP THE FLOW OF OXYGEN. THE END-USER DID NOT SEEK MEDICAL ATTENTION FOR THE ALLEGED INJURY. THE INFORMATION PRESENTED IS CONSISTENT WITH AN EVENT THAT MAY OCCUR WHEN A CONSERVING REGULATOR IS NOT PROPERLY ATTACHED TO THE CYLINDER, ALLOWING FOR A HIGH-PRESSURE LEAK. THE DEVICE IS BEING RETURNED TO INOVO FOR INVESTIGATION AND ROOT CAUSE ANALYSIS. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 17614477 ↗