BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDUCER, S8-3T MICRO TEE

    MDR report key: 3817477 · Received March 28, 2014

    Report

    Report Number
    3019216-2014-00003
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. AN EVALUATION OF THE TRANSDUCER IS PENDING THE DEVICE'S RETURN TO THE FACTORY. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE ANALYSIS ONCE COMPLETED. PMA/510(K)# K034003.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN S8-3T TRANSDUCER WAS UNABLE TO SEEK IMAGES DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185107 TRANSDUCER, S8-3T MICRO TEE IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. 989605420181 03CQN0

    Patients

    Seq Age Sex Outcome Treatment
    1