BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOWNSTREAM CARTRIDGE

    MDR report key: 20838804 · Received December 3, 2024

    Report

    Report Number
    2030964-2024-00001
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 12, 2024
    Report Date
    December 3, 2024
    Manufacturer
    THEROX, INC.
    Product Code
    MWG
    UDI-DI
    00862478000421
    PMA / PMN Number
    P170027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE DEVICE IN THE COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED, AND THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    FIFTY-EIGHT (58) MINUTES INTO SSO2 INFUSION, THE DOWNSTREAM CONSOLE (DS-2) (SN (B)(6) WENT INTO SHUTDOWN MODE, DISPLAYING ERROR CODE 14. IMMEDIATELY IT WAS OBSERVED THAT THERE WAS PATIENT BLOOD "LEAKING" FROM THE SSO2 CARTRIDGE TRANSDUCER. WITH LESS THAN TWO MINUTES REMAINING IN THE PROCEDURE, THE SSO2 THERAPY WAS DISCONTINUED. UPON REVIEW OF THE DOWNSTREAM CONSOLE'S LOG FILES, IT WAS DETERMINED THAT THE ISSUE WAS AN ISOLATED TRANSDUCER FAILURE. THERE WAS NO MALFUNCTION ON THE DOWNSTREAM CONSOLE AS IT DETECTED THE SENSOR FAILURE AND SHUT DOWN AUTOMATICALLY. THE DOWNSTREAM CONSOLE WAS PLACED BACK IN SERVICE. THE CARTRIDGE TRANSDUCER WAS REMOVED, PLACED INTO A LATEX GLOVE, AND SEALED/SECURED INTO A BIO-HAZARD MEDICAL BAG TO BE RETURNED FOR INVESTIGATION. THERE WAS MINIMAL BLOOD LOSS (<10CC), AND NO PATIENT COMPLICATIONS OR CONCERNS WERE NOTED. THE PATIENT WAS TRANSFERRED TO THE POST-CARE UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050204 DOWNSTREAM CARTRIDGE SUPERSATURATED OXYGEN THERAPY SYSTEM CARTRIDGE MWG THEROX, INC. DSC-2 W5834 00862478000421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown