BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIQ CVXI

    MDR report key: 21971899 · Received May 6, 2025

    Report

    Report Number
    3019216-2025-000189
    Event Type
    Death
    Date Received
    May 6, 2025
    Date of Event
    April 16, 2025
    Report Date
    October 1, 2025
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838114142
    PMA / PMN Number
    K132304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE SYSTEM ONSITE TO TRY AND DETERMINE THE CAUSE OF THE ULTRASOUND SYSTEM LOCKUP. DURING THE INSPECTION, THE SYSTEM PASSED ALL DIAGNOSTIC, FUNCTIONAL AND ELECTRICAL SAFETY TESTS. PHILIPS ENGINEERING PERFORMED A THOROUGH REVIEW OF SYSTEM LOG FILES AND FOUND ONE INSTANCE OF AN INFORMATIONAL MESSAGE ENTRY INDICATING POSSIBLE FOREIGN DEBRIS OR MOISTURE DETECTED IN THE CONNECTOR PORT OF THE SYSTEM OR TRANSDUCER. THE ULTRASOUND SYSTEM AND TRANSDUCER CONTINUE TO BE IN USE, WITH NO FURTHER ISSUES REPORTED. DISCUSSION WITH THE DIRECTOR OF CARDIOVASCULAR NON-INVASIVE IMAGING AT THE SITE PROVIDED A SUMMARY OF THE EVENT. THE PATIENT HAD MULTIPLE COMORBIDITIES AND WAS A HIGH-RISK SURGICAL PATIENT FOR A UROLOGICAL SURGERY. AFTER COMPLETION OF THE SURGERY DURING AWAKENING FROM GENERAL ANESTHESIA THE PATIENT WENT INTO EXTREMIS. THEY CODED THE PATIENT. THE HOSPITALS STANDARD PROCEDURE DURING A CODE IS TO PERFORM A TEE TO EVALUATE HEART FUNCTION AND RULE OUT PERICARDIAL EFFUSION. CPR WAS CONTINUING DURING THIS TIME. THE PATIENT PASSED AWAY FROM A HEART ATTACK AFTER 30 MINUTES. THE CARDIOVASCULAR DIRECTOR STATED THAT THE ULTRASOUND MACHINE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. THE SURGEON AND ANESTHESIOLOGIST BOTH AGREED THAT THE DELAY FOR THE TEE WOULD NOT HAVE CHANGED THE COURSE OF CARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EPIQ CVXI ULTRASOUND SYSTEM BECAME UNRESPONSIVE AND LOCKED UP DURING AN EXAMINATION WHERE A PATIENT WAS CODING. THE CLINICIAN HAD TO BRING IN ANOTHER SYSTEM IN AN ATTEMPT TO COMPLETE THE EXAMINATION. UNFORTUNATELY, THE PATIENT DID NOT RECOVER FROM THE CODE AND ULTIMATELY EXPIRED; HOWEVER, THE CUSTOMER HAS CLEARLY STATED THE ULTRASOUND DID NOT CAUSE THE PATIENT INCIDENT. 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
    1885790 EPIQ CVXI SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC EPIQ DIAGNOSTIC ULTRASOUND SYSTEM 00884838114142

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death