BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER, S8-3T MICRO TEE

    MDR report key: 3880063 · Received April 3, 2014

    Report

    Report Number
    3019216-2014-00005
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    January 16, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMAGE QUALITY DEGRADATION DURING CLINICAL USE OF THE S8-3T WAS REPORTED UNDER 21CFR 806 PER Z-2062-2011. CUSTOMERS WERE INFORMED ABOUT WHAT ACTIONS TO TAKE IN ORDER TO PREVENT RISKS TO PATIENTS. THE RETURNED DEVICE WAS EVALUATED AND CONFIRMED TO BE ASSOCIATED WITH THE ISSUE IDENTIFIED IN THE RECALL. THERE HAVE BEEN NO ADVERSE EVENTS AS A RESULT OF THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE HAVING IMAGE QUALITY DEGRADATION WITH THE S8-3T PART TRANSDUCER. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME TRANSDUCER. THE ISSUE DID NOT AFFECT PATIENT OUTCOME. NO PATIENT OR USE WAS HARMED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200966 TRANSDUCER, S8-3T MICRO TEE IYO, IYN, ITX IYO PHILIPS ULTRASOUND, INC. 989606379471

    Patients

    Seq Age Sex Outcome Treatment
    1