BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD SLIDE DISPOSABLE STERILE DOPPLER PROBE

    MDR report key: 4315083 · Received November 11, 2014

    Report

    Report Number
    3006680097-2014-00006
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 1, 2014
    Report Date
    November 14, 2014
    Manufacturer
    THD SPA-CORREGGIO (RE) - ITALY
    Product Code
    JAF
    PMA / PMN Number
    K090009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A CASE, THERE WAS NO SOUND FROM THE THD DOPPLER PROBE DEVICE. THE STAFF NOTICED THE SIGNAL IN THE DISPLAY OF THE REVOLUTION DEVICE, BUT NO SOUND COULD BE HEARD OUT OF IT. THEN, A NEW THD DOPPLER PROBE WAS USED AND THE TREATMENT INITIATED AND COMPLETED AS USUAL. A "WARNING" MESSAGE WAS DISPLAYED BY THE THD REVOLUTION, ALTHOUGH THE "WARNING NUMBER" WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726720 THD SLIDE DISPOSABLE STERILE DOPPLER PROBE DOPPLER PROBE DISPOSABLE JAF THD SPA-CORREGGIO (RE) - ITALY 800063

    Patients

    Seq Age Sex Outcome Treatment
    1