BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8-3T MICRO TEE TRANSDUCER

    MDR report key: 6152758 · Received December 7, 2016

    Report

    Report Number
    3019216-2016-00045
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Report Date
    November 22, 2016
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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 IN THE WINDOW, DAMAGE TO THE WINDOW, AND A DENTED SHAFT. THE CAUSE OF THIS DAMAGE IS INDICATIVE OF IMPROPER HANDLING AND MAINTENANCE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING A WEAK IMAGE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801587 S8-3T MICRO TEE TRANSDUCER S8-3T MICRO TEE TRANSDUCER ITX PHILIPS ULTRASOUND, INC 03C2B5

    Patients

    Seq Age Sex Outcome Treatment
    1