BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD SLINE DOPPLER PROBE 10 SHOTS NON STERILE

    MDR report key: 4373474 · Received December 22, 2014

    Report

    Report Number
    3006680097-2014-00007
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    November 20, 2014
    Report Date
    December 22, 2014
    Manufacturer
    THD SPA
    Product Code
    JAF
    PMA / PMN Number
    K070815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO (B)(4). ADDITIONAL INFO COULD BE PROVIDED UPON COMPLETION OF THE TECHNICAL INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, "BEFORE THE CASE, THE THD DOPPLER PROBE WAS NEW, AND WHEN THE CASE STARTED, IT WAS NOT PICKING UP BLOOD VESSEL SIGNALS. THE SURGEON INCREASED PT BLOOD PRESSURE BUT NO SIGNAL COULD BE HEARD. THE SYSTEM WAS RESTARTED AND TRIED TO USE AGAIN THE SAME DOPPLER, BUT STILL NO SIGNAL WAS HEARD AND DETECTED. ANOTHER THD DOPPLER PROBE WAS USED AND IT WORKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843160 THD SLINE DOPPLER PROBE 10 SHOTS NON STERILE DOPPLER PROBE NON STERILE JAF THD SPA 7000001B NA

    Patients

    Seq Age Sex Outcome Treatment
    1