BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IE33 DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 21890615 · Received April 23, 2025

    Report

    Report Number
    21890615
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    January 6, 2025
    Report Date
    April 16, 2025
    Manufacturer
    PHILIPS ULTRASOUND LLC
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHILIPS TEE [TRANSESOPHAGEAL ECHOCARDIOGRAM] MACHINE FROZE AND WAS NOT RESPONDING TO THE BUTTONS/CONTROLS ON THE PROBE OR THE COMPUTER CONSOLE. THE ANESTHESIA TECH AND ECHO TECH BOTH TRIED TO TROUBLESHOOT THE PROBLEM, AND THE MACHINE HAD TO BE REBOOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674398 IE33 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX PHILIPS ULTRASOUND LLC 8500-0082-01

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown