BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8-3T MICRO TEE TRANSDUCER

    MDR report key: 6198934 · Received December 22, 2016

    Report

    Report Number
    3019216-2016-00046
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Report Date
    December 8, 2016
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE TRANSDUCER WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS RETURN AND INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE TRANSDUCER CONFIRMED OIL SEPARATION AND DAMAGE TO THE WINDOW. A SIGNIFICANT BUILDUP OF DEBRIS ON THE TIP CAP, WINDOW, BENDING NECK, AND BEAD WAS ALSO NOTED. THE CAUSE OF THE EXTENSIVE DAMAGE TO THIS DEVICE IS INDICATIVE OF IMPROPER HANDLING AND MAINTENANCE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS NOT PRODUCING AN IMAGE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849722 S8-3T MICRO TEE TRANSDUCER S8-3T MICRO TEE TRANSDUCER ITX PHILIPS ULTRASOUND, INC B1GTVH

    Patients

    Seq Age Sex Outcome Treatment
    1