BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 12778307 · Received November 9, 2021

    Report

    Report Number
    12778307
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 25, 2021
    Report Date
    November 1, 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
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SENSOR ERROR, NEW DONGLE USED, PROBLEM PERSISTED. NEW SOUNDSTAR OPENED, PROCEDURE COMPLETED WITHOUT INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676272 SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. R10439011 2161705 10888551045087

    Patients

    Seq Age Sex Outcome Treatment
    1 27375 DA Male