BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIQ 7

    MDR report key: 23253093 · Received October 9, 2025

    Report

    Report Number
    3019216-2025-000351
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 10, 2025
    Report Date
    January 8, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K132304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH INVESTIGATION WAS PERFORMED TO DETERMINE THE CAUSE OF THE REPORTED PROBLEM. THE PHILIPS SERVICE ENGINEER REPLACED THE CONTROL PANEL ARM GAS STRUTS TO RESOLVE THE CUSTOMER¿S ISSUE. THE INVESTIGATION CONCLUDED THE CAUSE LEADING TO THE FAILURE WAS BOTH SEALS ON THE GAS STRUTS WERE COMPROMISED. TYPICALLY, ONLY ONE STRUT SEAL FAILS AT A TIME AND IS THEN SERVICED AND REPLACED. IN THIS INSTANCE, BOTH GAS STRUT SEALS FAILED AROUND THE SAME TIME WHICH CAUSED THE CONTROL PANEL TO LOWER FASTER THAN ANTICIPATED. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED POST REPAIR.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THE CONTROL PANEL ON THEIR EPIQ 7C ULTRASOUND SYSTEM DROPPED RAPIDLY AND CAUSED INJURY TO THE ULTRASOUND TECHNICIAN. THE INJURY TO THE SHOULDER RESULTED IN PRESCRIBED PHYSICAL THERAPY SESSIONS WHICH ARE ON-GOING AND PRESCRIPTION PAIN MEDICATION FOR PAIN MANAGEMENT. THE PHILIPS SERVICE ENGINEER REPLACED THE CONTROL PANEL ARM GAS STRUTS TO RESOLVE THE CUSTOMER¿S ISSUE. 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
    2508991 EPIQ 7 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention