BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX

    MDR report key: 22789902 · Received August 12, 2025

    Report

    Report Number
    3019216-2025-000278
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    August 4, 2025
    Report Date
    December 5, 2025
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    IYN
    UDI-DI
    00884838123960
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH INVESTIGATION WAS PERFORMED TO IDENTIFY THE CAUSE OF THE REPORTED ISSUE. THE ENGINEERING TEAM DETERMINED THIS WAS RELATED TO ONE OR MORE BLANK DICOM TAGS WHEN EXPORTING DATA CAUSING THE SYSTEM TO LOCKUP WHEN ATTEMPTING TO REVIEW IMAGES. WHEN ALL THESE TAGS ARE LEFT BLANK, THE SOFTWARE CREATES A DUPLICATE STUDY DESCRIPTION LEADING TO A LOCKUP WHEN ATTEMPTING TO OPEN THE IMAGES AND PREVENTING EXPORT OF THE IMAGES. WHEN THE PHYSICIAN SELECTS THE MWL STUDY ON THE PATIENT DATA ENTRY SCREEN, THE STUDY BECOMES CORRUPTED. IF THE SYSTEM BECOMES UNRESPONSIVE BECAUSE OF THIS ISSUE, THE USER WILL SEE AN EHA (ERROR CODE), AND THE SYSTEM WILL RETURN TO NORMAL OPERATION AFTER A REBOOT.

    Description of Event or Problem · 0

    PROPOSED B5 TEXT: A CUSTOMER REPORTED THEIR EPIQ CVX ULTRASOUND SYSTEM BECAME UNRESPONSIVE DURING A MITRAL VALVE CLIPPING, TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) PROCEDURE USING AN X11-4T TRANSDUCER. AFTER RESTARTING THE SYSTEM, A BASELINE VIEW WAS REQUESTED DURING IMAGE ACQUISITION. AT THAT MOMENT, THE SYSTEM LOCKED UP AGAIN. A DECISION WAS MADE TO RETRIEVE ANOTHER ULTRASOUND SYSTEM AND TRANSDUCER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE SYSTEM HAS BEEN REMOVED FROM SERVICE. PHILIPS HAS STARTED AN INVESTIGATION AND UPON COMPLETION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258909 EPIQ CVX SYSTEM,IMAGING,PULSEDDOPPLER,ULTRASONIC IYN PHILIPS NORTH AMERICA LLC EPIQ DIAGNOSTIC ULTRASOUND SYSTEM 00884838123960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown