BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIQ ELITE DIAGNOSTIC ULTRASOUND CHINA

    MDR report key: 23570840 · Received November 17, 2025

    Report

    Report Number
    3019216-2025-000439
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 28, 2025
    Report Date
    December 4, 2025
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838102620
    PMA / PMN Number
    K200304
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS INITIALLY REPORTED FOR AN ALLEGATION OF A SERIOUS INJURY. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED THAT VERIFIED THERE WAS NO ACTUAL HARM OR INJURY ASSOCIATED WITH THIS EVENT. THERE WAS NO MISSED OR MISDIAGNOSIS ASSOCIATED WITH THIS EVENT. THERE WAS NO DETERIORATION OF THE PATIENT'S CONDITION ASSOCIATED WITH THIS EVENT. THE EXAM WAS COMPLETED ON THE SAME SYSTEM. THE REPORTED PROBLEM INDICATED IN THIS EVENT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IF IT WERE TO REOCCUR.

    Description of Event or Problem · 0

    PHILIPS RECEIVED AN NMPA#(B)(4). IT WAS REPORTED A CUSTOMER¿S EPIQ ELITE ULTRASOUND SYSTEM, IN USE WITH AN UNSPECIFIED ABDOMINAL TRANSDUCER, HAD IMAGE QUALITY ISSUES. DURING AN ABDOMINAL EXAMINATION, THERE WAS SIGNIFICANT INTERFERENCE RESULTING IN BLURRY IMAGES AND UNCLEAR BLOOD FLOW. THE CUSTOMER ALLEGES A SERIOUS INJURY OCCURRED, HOWEVER THERE IS INSUFFICIENT INFORMATION REGARDING THE PATIENT OUTCOME AT THIS TIME. 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
    281217 EPIQ ELITE DIAGNOSTIC ULTRASOUND CHINA SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 00884838102620

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other