BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND

    MDR report key: 11640484 · Received April 9, 2021

    Report

    Report Number
    11640484
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 7, 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

    IMAGE WAS REVERSED WHEN REPROCESSED SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER WAS CONNECTED. NEW CATHETER USED WORKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538748 SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. R10439011 2147431 10888551045087

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA