BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER X7-2T

    MDR report key: 20469847 · Received October 17, 2024

    Report

    Report Number
    20469847
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 25, 2024
    Report Date
    September 25, 2024
    Manufacturer
    PHILIPS ULTRASOUND LLC
    Product Code
    ITX
    UDI-DI
    00884838061668
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A PATIENT WHO WAS POST-OP FROM BIOPROSTHETIC MITRAL VALVE AND TRICUSPID VALVE REPLACEMENTS WAS DECOMPENSATING FOR UNKNOWN REASONS. WE WANTED TO PERFORM A TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) TO ASSESS WHETHER THE PATIENT HAD CARDIOGENIC SHOCK IN ADDITION TO SEPTIC SHOCK. THE TEE PROBE IN THE CVICU (CARDIOVASCULAR INTENSIVE CARE UNIT) WAS SCRATCHED AND IMAGES OBTAINED WITH THE PROBE WERE NEARLY UNINTERPRETABLE. AFTER A FEW MINUTES THE PROBE STOPPED WORKING COMPLETELY. WE WERE UNABLE TO ASSESS THIS PATIENT'S RIGHT HEART FUNCTION. UNFORTUNATELY, THIS SIGNIFICANTLY DELAYED THE PATIENT GOING ON ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) AS WE NEEDED THE IMAGING TO DETERMINE WHICH CANNULA TO USE. EVENTUALLY, WE WERE ABLE TO USE A PEDIATRIC TEE PROBE (THE ONLY ONE AVAILABLE) WHICH PRODUCED SUBOPTIMAL IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463560 TRANSDUCER X7-2T TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX PHILIPS ULTRASOUND LLC 989605414122 F0B6JW 00884838061668

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male