BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER X8-2T

    MDR report key: 24495255 · Received March 3, 2026

    Report

    Report Number
    24495255
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 24, 2026
    Manufacturer
    PHILIPS ULTRASOUND LLC
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS SEDATED AND PROBE WAS INSERTED BY CARDIOLOGIST. PROBE WAS MALFUNCTIONING AND WAS RESET MULTIPLE TIMES. PROCEDURE WAS UNSUCCESSFUL AND PROBE WAS REMOVED. PROCEDURE WAS ABORTED AND UNABLE TO FINISH DUE TO TECHNICAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298701 TRANSDUCER X8-2T SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO PHILIPS ULTRASOUND LLC 989605455171

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Other