BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 11874881 · Received May 25, 2021

    Report

    Report Number
    11874881
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    May 12, 2021
    Report Date
    May 13, 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

    MAGNETIC SENSOR ERROR, DID ENTER THE BODY BUT DID NOT CAUSE HARM, CATHETER EXCHANGED FOR NEW ONE. MAGNETIC SENSOR ERROR ON NEW CATHETER, DID ENTER THE BODY BUT DID NOT CAUSE HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773213 SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. R10439011 2148301 10888551045087

    Patients

    Seq Age Sex Outcome Treatment
    1 27375 DA