BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIQ 7

    MDR report key: 18980566 · Received March 26, 2024

    Report

    Report Number
    3019216-2024-00038
    Event Type
    Death
    Date Received
    March 26, 2024
    Date of Event
    March 20, 2024
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838047693
    PMA / PMN Number
    K132304
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE EPIQ 7 ULTRASOUND SYSTEM WAS ASSOCIATED WITH A PATIENT DEATH EVENT. A PATIENT WAS LOCATED IN THE ICU INTENSIVE CARE UNIT OF THE FACILITY AND REQUIRED RESUSCITATION. THE ULTRASOUND SYSTEM WOULD HAVE BEEN USED DURING THE RESUSCITATION EFFORTS; HOWEVER, WHEN THE STAFF MEMBER RETRIEVED THE SYSTEM FROM THE STORAGE ROOM, IT WAS OVERLOOKED THE SYSTEM WAS CONNECTED TO THE POWER SUPPLY AND THE PLUG WAS TORN OUT OF THE SOCKET. DUE TO THE DAMAGE OF THE DEVICE THAT OCCURRED, THE DEVICE WAS NOT USED ON THE PATIENT, BUT RATHER ANOTHER DEVICE WAS USED. THE SERVICE ENGINEER EVALUATED THE SYSTEM AND FOUND THE SYSTEM COULD BE TURNED ON AND STARTED. THE SYSTEM LOGS SHOWED BATTERIES AND AC POWER FAILURES. THE ORIGINAL POWER CABLE WAS NOT INSTALLED. THE POWER SUPPLY, POWER CABLE AND BATTERIES WERE ORDERED FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500083 EPIQ 7 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 00884838047693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death