BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER S8-3T MICRO TEE

    MDR report key: 3902608 · Received May 9, 2014

    Report

    Report Number
    3019216-2014-00008
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    February 20, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    ITX
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION OF THE RETURNED TRANSDUCER CONFIRMED POOR IMAGE QUALITY. THE ROOT CAUSE WAS DETERMINED TO BE AIR VOIDS IN THE ACOUSTIC WINDOW. THE SUPPLIER IS TAKING CORRECTIVE/PREVENTIVE ACTION TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE S8-3T TRANSDUCER WAS EXHIBITING POOR IMAGE QUALITY DURING CLINICAL USE. HOWEVER, THE PROCEDURE WAS COMPLETED WITH THE SAME TRANSDUCER. THE ISSUE DID NOT AFFECT PT OUTCOME. NO PT OR USER HAS BEEN HARMED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282362 TRANSDUCER S8-3T MICRO TEE IVO IYN ITX ITX PHILIPS ULTRASOUND, INC. 453561667831 B0JRTW

    Patients

    Seq Age Sex Outcome Treatment
    1