BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOVO INC.

    MDR report key: 18749618 · Received February 21, 2024

    Report

    Report Number
    1062191-2024-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    July 26, 2023
    Report Date
    April 17, 2024
    Manufacturer
    INOVO INC.
    Product Code
    NFB
    UDI-DI
    00814470020044
    PMA / PMN Number
    K103392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INOVO INC. PREVIOUSLY REPORTED THE INCORRECT DATE FOR SECTION G3, DATE RECEIVED BY MANUFACTURER AS 7/26/2023. THE CORRECT DATE FOR SECTION G3, DATE RECEIVED BY MANUFACTURER IS 1/3/2024.

    Additional Manufacturer Narrative · 0

    INOVO INC. PREVIOUSLY REPORTED THE INCORRECT DATE FOR SECTION G3, DATE RECEIVED BY MANUFACTURER AS 7/26/2023. THE CORRECT DATE FOR SECTION G3, DATE RECEIVED BY MANUFACTURER IS 2/15/2024.

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48489 INOVO INC. CONSERVER, OXYGEN NFB INOVO INC. OM-900 00814470020044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other