BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOVO

    MDR report key: 17614477 · Received August 24, 2023

    Report

    Report Number
    3005328749-2023-00002
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Report Date
    August 24, 2023
    Manufacturer
    INOVO INC
    Product Code
    NFB
    UDI-DI
    00814470020044
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070636 INOVO CONSERVER NFB INOVO INC OM-900 00814470020044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown