BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD SLIDE DOPPLER PROBE 5 SHOTS NON STERILE

    MDR report key: 4261598 · Received October 30, 2014

    Report

    Report Number
    3006680097-2014-00004
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 31, 2014
    Manufacturer
    THD SPA
    Product Code
    JAF
    PMA / PMN Number
    K081429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING TO RECEIVE THE DEVICE AT THE HEADQUARTERS OF (B)(6), IN ORDER TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 1

    THE DOCTOR OPENED A NEW THD OPERATION BOX, TOOK OUT A NEW THD DOPPLER PROBE AND CONNECTED IT TO THE THD EVOLUTION DEVICE. THE PROBE DID NOT GIVE ANY SIGNAL DURING OPERATION, IT ONLY HISSED. THE DOCTOR RESTARTED THD EVOLUTION, BUT THE PROBLEM (HISS) REMAINED. THE DOCTOR TOOK ANOTHER THD DOPPLER PROBE (FROM ANOTHER BOX) AND COMPLETED OPERATION SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694848 THD SLIDE DOPPLER PROBE 5 SHOTS NON STERILE DOPPLER PROBE NON STERILE JAF THD SPA 800056B NA

    Patients

    Seq Age Sex Outcome Treatment
    1