BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ 7C ULTRASOUND SYSTEM

    MDR report key: 16742279 · Received April 14, 2023

    Report

    Report Number
    16742279
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 23, 2023
    Report Date
    April 10, 2023
    Manufacturer
    PHILIPS ULTRASOUND, LLC
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE ECHO ULTRASOUND DEVICE SHUT DOWN DURING A STRUCTURAL HEART CASE. THE ERROR CODE ON THE UNIT STATED, "RECONNECT THE TRANSDUCER AND RESELECT. DIAGCODE: 007". THE ECHO TECH HAD TO BRING IN A NEW UNIT IN THE ROOM TO FINISH THE CASE. MANUFACTURER RESPONSE FOR ULTRASOUND SYSTEM, EPIQ 7C (PER SITE REPORTER). THE PHILIPS SERVICE REP WAS CALLED OUT TO REPAIR THE UNIT. WE ARE WAITING ON RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129772 EPIQ 7C ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, LLC 795201

    Patients

    Seq Age Sex Outcome Treatment
    1 16425 DA Unknown