BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 12672205 · Received October 21, 2021

    Report

    Report Number
    12672205
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    October 6, 2021
    Report Date
    October 8, 2021
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    UDI-DI
    10888551045087
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPROCESSED ICE CATHETER UNABLE TO DETECT TRANSDUCER WHEN CONNECTED TO ICE MACHINE, DID NOT ENTER BODY, TROUBLESHOOTING BY CARTO REPRESENTATIVE WITHOUT RESOLUTION, NEW DEVICE OPENED AND UTILIZED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575211 SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. R10439011 2157922 10888551045087

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA