BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER, S8-3T MICRO TEE

    MDR report key: 4063353 · Received August 8, 2014

    Report

    Report Number
    3019216-2014-00018
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). EVAL OF THE TRANSDUCER WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS RETURN. ADDITIONAL PMA# K034003.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN S8-3T TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THE PROCEDURE IN PROGRESS WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473127 TRANSDUCER, S8-3T MICRO TEE IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. 989605420181 B0JRVX

    Patients

    Seq Age Sex Outcome Treatment
    1