BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIQ 7

    MDR report key: 23547039 · Received November 13, 2025

    Report

    Report Number
    3019216-2025-000433
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 4, 2025
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838109995
    PMA / PMN Number
    K132304
    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 SERIOUS INJURY ASSOCIATED WITH THIS EVENT. THE ROUTINE TEE ECHOCARDIOGRAM WAS ABLE TO BE COMPLETED. IT WAS CLARIFIED THE PATIENT DID NOT FEEL ANY THROAT DISCOMFORT. THE EMOTIONAL TENSION CAUSED THE PATIENT'S BLOOD PRESSURE TO INCREASE TO AN UNSPECIFIED LEVEL BUT DID NOT REQUIRE ANY MEDICAL INTERVENTION OR AFFECT THE OUTCOME. 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 7C ULTRASOUND SYSTEM, IN USE WITH AN X7-2T TRANSDUCER, WAS NOT AVAILABLE DUE TO A SYSTEM LOCK UP. THE SYSTEM WAS EXCHANGED, BUT THE TRANSDUCER COULD NOT BE USED AND REQUIRED A REPLACEMENT AS WELL. THE PATIENT EXPERIENCED THROAT DISCOMFORT AND EMOTIONAL EXCITEMENT. THE PATIENT'S BLOOD PRESSURE INCREASED TO AN UNSPECIFIED LEVEL. THE PATIENT REQUIRED REASSURANCE ALONG WITH INFORMATION REGARDING THE TRANSDUCER REPLACEMENT. 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
    1929596 EPIQ 7 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM 00884838109995

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other