BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUNDSTAR

    MDR report key: 18542707 · Received January 19, 2024

    Report

    Report Number
    18542707
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    November 27, 2023
    Report Date
    December 1, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER PLACEMENT INTO THE PATIENT, THE SOUNDSTAR ULTRASOUND CATHETER FAILED TO COMMUNICATE WITH THE CARTO SYSTEM. CLINICAL SITE NOTIFIED MFG REP DIRECTLY. MANUFACTURER RESPONSE FOR DIAGNOSTIC ULTRASOUND CATHETER, SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER (PER SITE REPORTER) CLINICAL SITE NOTIFIED MFG REP DIRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476093 SOUNDSTAR CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10439072 G4120210

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown