BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X5-1C TRANSDUCER

    MDR report key: 18228773 · Received November 29, 2023

    Report

    Report Number
    18228773
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    July 11, 2023
    Report Date
    September 29, 2023
    Manufacturer
    PHILIPS ULTRASOUND LLC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PHILIPS ULTRASOUND X5-1C TRANSDUCER IS GIVING A ERROR MESSAGE AND IS NOT "DETECTABLE" ON ANY OF THE EPIC MACHINES. PLUGGED THE PROBE IN TO ALL THE EPIC MACHINES AND RECEIVED THE SAME ERROR MESSAGE. PHILIPS DIAGNOSED AND SENT REPLACEMENT PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67903 X5-1C TRANSDUCER SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO PHILIPS ULTRASOUND LLC. 989606702251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown