BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD SLIDE DOPPLER PROBE 5 SHOTS NON STERILE

    MDR report key: 4427223 · Received January 9, 2015

    Report

    Report Number
    3006680097-2015-00002
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Date of Event
    November 1, 2014
    Report Date
    January 8, 2015
    Manufacturer
    THD SPA
    Product Code
    JAF
    PMA / PMN Number
    K081429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO TDH SPA (ITALY). ADD'L INFO COULD BE PROVIDED UPON COMPLETION OF THE TECHNICAL INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, "NO BLOOD VESSEL SIGNAL FROM THE THD DOPPLER PROBE DEVICE DURING THD TREATMENT, SILENT". A NEW THD DOPPLER PROBE WAS USED AND THE TREATMENT WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20083 THD SLIDE DOPPLER PROBE 5 SHOTS NON STERILE DOPPLER PROBE NON STERILE JAF THD SPA 800056B NA

    Patients

    Seq Age Sex Outcome Treatment
    1