BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVXI

    MDR report key: 17075518 · Received June 6, 2023

    Report

    Report Number
    3019216-2023-00077
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 10, 2023
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838097940
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A CUSTOMER ENCOUNTERED AN INCIDENT WHERE A PATIENT¿S DATA WAS MIXED WITH ANOTHER EXAM WHILE USING THEIR EPIQ ULTRASOUND SYSTEM. THERE WAS NO ALLEGATION OF PATIENT HARM OR INJURY. ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER INDICATES THE EPIQ ULTRASOUND SYSTEM WAS NOT THE CORRECT DEVICE FOR THE ALLEGED MALFUNCTION. THE FIELD SERVICE ENGINEER DETERMINED AN ECHO NAVIGATOR SYSTEM WAS BEING USED AT THE TIME OF REPORTED EVENT, AND NO ALLEGATION WAS RECEIVED AGAINST AN EPIQ ULTRASOUND SYSTEM. THE ALLEGATION WAS FORWARDED TO THE PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. FOR REVIEW AND REPORTABILITY DETERMINATION. NO ADDITIONAL REVIEW IS REQUIRED FOR THE EPIQ ULTRASOUND SYSTEM.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE A PATIENT¿S DATA WAS MIXED WITH ANOTHER EXAM WHILE USING THEIR EPIQ ULTRASOUND SYSTEM. ACCORDING TO THE CUSTOMER, IMAGES WERE BEING ADDED TO THE WRONG PATIENT STUDY. THE USER IDENTIFIED THE DATA MIX-UP, AND THERE WAS NO ALLEGATION OF ALTERED PATIENT OUTCOMES AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234113 EPIQ CVXI SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC EPIQ DIAGNOSTIC ULTRASOUND SYSTEM 00884838097940

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown