BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    SOUNDSTAR

    MDR report key: 16120697 · Received January 9, 2023

    Report

    Report Number
    16120697
    Event Type
    No answer provided
    Date Received
    January 9, 2023
    Date of Event
    November 23, 2022
    Report Date
    December 19, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CARTO SYSTEM WAS UNABLE TO RECOGNIZE THE SOUNDSTAR ECO ULTRASOUND CATHETER. THE CATHETER WAS REPLACED WITH ANOTHER SOUNDSTAR. MANUFACTURER RESPONSE FOR CATHETER, SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER (PER SITE REPORTER). PER RL, MANUFACTURER NOTIFIED BY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300493 SOUNDSTAR CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10439072 G4088947

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown