BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX

    MDR report key: 21842302 · Received April 15, 2025

    Report

    Report Number
    3019216-2025-000173
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    November 20, 2023
    Report Date
    August 5, 2025
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH INVESTIGATION WAS UNABLE TO BE PERFORMED TO DETERMINE THE CAUSE OF THE REPORTED PROBLEM. THE TRANSDUCER WAS NO LONGER AVAILABLE; THEREFORE, NO REPAIR OR EVALUATION DATA COULD BE OBTAINED. NO ADDITIONAL INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 0

    AS PART OF CAPA 5677695, IT WAS IDENTIFIED THAT RETROSPECTIVE REVIEW ACTIVITIES WERE WARRANTED FOR INTRACAVITY TRANSDUCER DAMAGE IF PHYSICALLY SPLIT, FRACTURED, OR CONTAINS SHARP EDGES ON THE TRANSDUCER, REGARDLESS OF WHETHER THE DEVICE IS IN CLINICAL USE. PHILIPS ULTRASOUND IS REPORTING THIS COMPLAINT AS PART OF THE RETROSPECTIVE REVIEW COMPLETED FOR INTRACAVITY TRANSDUCER DAMAGE. IT WAS REPORTED THE X8-2T TRANSDUCER HAD THE SEAL AROUND THE LENS COMES OFF. THIS TRANSDUCER WAS ASSOCIATED WITH AN EPIQ CVX ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE AND REPLACED THE TRANSDUCER TO RESOLVE THE CUSTOMER¿S IMMEDIATE CONCERNS. 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
    109307 EPIQ CVX SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC EPIQ CVX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown